E.P.A.R s  Editing

Επεξεργασία E.P.A.R s

 ΟΔΗΓΙΕΣ  (κλικ για εμφάνιση/απόκρυψη)

ΒΑΣΙΚΕΣ ΛΕΙΤΟΥΡΓΙΕΣ ...για βιαστικούς 😀


1. Κάντε κλικ στο αρχικό γράμμα της ονομασίας του φαρμάκου που αναζητάτε
 (η περιοχή αυτή με κουμπιά της Αγγλικής αλφαβήτου βρίσκεται παρακάτω).
2. Επιλέξτε εμπορική ονομασία (αμέσως κάτω από την Αγγλική αλφάβητο).
3. Μεταφέρεστε αυτόματα στην κάρτα του φαρμάκου που επιλέξατε.


ΑΝΑΛΥΤΙΚΟΤΕΡΑ


Παρουσιάζουμε τις περιλήψεις των E.P.A.Rs (European Public Assessment Reports = Ευρωπαϊκές Δημοσίες Εκθέσεις Αξιολόγησης) για το κοινό, από τον ΕΜΑ* (European Medicines Agency = Ευρωπαϊκός Οργανισμός Φαρμάκων), όλων των κεντρικά αδειοδοτημένων φαρμάκων.
*Για όσους δε γνωρίζουν, ο ΕΜΑ είναι (με 'δυο λέξεις') η ανώτατη αρχή για τα φάρμακα στην Ευρωπαϊκή Ένωση.

Πρόκειται για απλές και κατανοητές (όσον αφορά στον απλό αναγνώστη) αναφορές για όσα φαρμακευτικά προϊόντα αδειοδοτούνται μέσω Κεντρικής Διαδικασίας (Central Procedure) και -κατ' επέκταση- μπορούν να κυκλοφορούν σε όλες τις χώρες της Ευρωπαϊκής ένωσης.

Εκτός της μετατροπής (των περίπου 1400 αρχείων PDF όλων αυτών των φαρμάκων) σε επεξεργάσιμο Αγγλικό κείμενο, έχουμε συμπεριλάβει τα original PDFs αυτών των E.P.A.Rs σε 23 γλώσσες της EU στις οποίες μεταφράστηκαν.
Μπορείτε να επιλέξετε γλώσσα κάνοντας κλικ στο μπλε banner λίγο πριν το τέλος της κάρτας φαρμάκου (στο banner αναγράφεται: "Read the original document in your language")

Στην Ελλάδα (Οκτώβριος 2023) από τα περίπου 1400 κεντρικά αδειοδοτημένα φάρμακα, κυκλοφορούν περίπου τα 600.



ΕΠΕΞΕΡΓΑΣΙΑ ΚΕΙΜΕΝΟΥ

ΣΗΜΑΝΤΙΚΟ: Η επεξεργασία κειμένου δεν προσφέρεται για οθόνες μικρότερες των 440px.

  • Εαν επιθυμείτε -εκτός της ανάγνωσης- να επεξεργαστείτε την EPAR και να προσθέσετε τα δικά σας σχόλια και σημειώσεις, κάντε κλικ μέσα στο κείμενο της κάρτας.
    Γύρω από το κείμενο θα εμφανιστεί πλαίσιο, δηλώνοντας έτσι ότι είστε σε 'κατάσταση επεξεργασίας' (edit mode).

  • Προσθέστε, αφαιρέστε, πληκτρολογείστε, επικολλήστε κείμενα ή και εικόνες.

  • Μορφοποιήστε το κείμενο (αφού το επιλέξετε) με τη βοήθεια του πλαισίου μορφοποίησης του Farmako.net Editor®
    Το πλαίσιο Μορφοποίησης βρίσκεται κάτω από την Αγγλική αλφάβητο και δίπλα από τις εμπορικές ονομασίες.

  • Για να προσθέσετε τις σημειώσεις σας, τις λέξεις-κλειδιά ή τις ετικέτες (που θα σας βοηθήσουν να θυμάστε το φάρμακο που διαβάζετε όσο καλύτερα μπορείτε), κάντε κλικ μέσα στο μπλε πλαίσιο (στο κάτω μέρος της κάρτας, που περιέχει το σύμβολο '#') και ξεκινήστε να γράφετε.
    Όταν τελειώσετε με αυτήν τη σημείωση - και ενώ βρίσκεστε μέσα στο μπλε πλαίσιο - πατήστε enter στο πληκτρολόγιό σας για να προσθέσετε ένα νέο. Προσθέστε όσα μπλε πλαίσια θέλετε.

  • Όταν είστε έτοιμοι, πατήστε εκτύπωση (στο κάτω μέρος της κάρτας) για εκτύπωση σε χαρτί ή pdf, δημιουργώντας έτσι τη δική σας έντυπη ή ηλεκτρονική βιβλιοθήκη από σύντομες μονογραφίες με το προσωπικό σας ύφος, σημειώσεις και παρατηρήσεις για όσα φάρμακα είναι του ενδιαφέροντος σας.

  • Αν είστε επαγγελματίας υγείας μπορείτε (στο κάτω μέρος κάθε κάρτας) να μεταβείτε στο site του EMA, αποκτώντας πρόσβαση σε πρόσθετες πληροφορίες τις οποίες στη συνέχεια μπορείτε να αντιγράψετε και να επικολλήσετε εδώ.
 INSTRUCTIONS  (click to show/hide)

QUICK GUIDE ...for those in a rush 😀


1. Tap the first letter of the medicine's name you're searching for
 (you'll find the English alphabet buttons below).
2. Pick the brand name right after the English alphabet.
3. You'll be automatically taken to the card of the drug you selected.


DETAILED GUIDE


We've got E.P.A.Rs (European Public Assessment Reports) summaries for the public, from the ΕΜΑ* (European Medicines Agency) for All of Central Procedure Authorized Medicines
*For those who aren't familiar, EMA is the top authority for medicines in the European Union.

These reports explain pharmaceutical products in a way that's easy to understand for most readers.

Because of these products are licensed through the Central Procedure, they can be circulated across all European Union countries.

In addition to converting (the approximately 1400 PDF files of all these medicines) into editable English text, we have included the original PDFs of these E.P.A.Rs in 23 EU languages into which they were translated.
You can choose a language by clicking on the blue banner just before the end of the medicine card (the banner says: "Read the original document in your language")



TEXT EDITING

IMPORTANT: Text editing is not available for screens smaller than 440 pixels.

  • If you want to do more than just read, and you wish to edit the EPAR by adding your comments and notes, simply click within the text of the card.
    A box will pop up around the text, letting you know that you're in 'edit mode'.

  • You can add, remove, type, paste texts, or images.

  • After selecting the text you want, you can format it using the 'Farmako.net Editor®' format box, located below the English alphabet and beside the brand names.

  • To add your notes, keywords or tags to help you remember the medicine you're reading as best you can, click inside the blue box (near the end of the card, with '#' in it) and start writing.
    When you're done with this note - and while you're inside the blue box - press enter on your keyboard to add a new one. Add as many blue boxes as you want.

  • Once you're done, hit Print at the bottom of the card to create your personalized collection of concise monographs in your unique style, including notes and insights about any drugs that catch your interest, either on paper or as a PDF for your electronic library.

  • If you are a healthcare professional, there is a link at the bottom of each card that you can click to visit the medicine's E.M.A page, accessing additional information which you can then copy and paste here.



Κλικ στο αρχικό γράμμα της ονομασίας του φαρμάκου που αναζητάτε
Click on the initial letter of the name of the medicine you are looking for

Εμπορικές ονομασίες / Brand names

Μορφοποίηση / Formatting Farmako.net Editor®

Για να φανούν τα Ελληνικά, επιλέξτε
πρώτα μια οποιαδήποτε άλλη γλώσσα.

Abasaglar


What is Abasaglar and what is it used for?

Abasaglar is a medicine that contains the active substance insulin glargine. It is used in adults and children over the age of two for the treatment of diabetes.Abasaglar is a 'biosimilar medicine'. This means that Abasaglar is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Abasaglar is Lantus. For more information on biosimilar medicines, see here.

How is Abasaglar used?

Abasaglar is injected under the skin in the abdominal wall (tummy), the thigh, or the deltoid region(upper arm). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.Abasaglar is injected once a day at the same time each day. The dose is adjusted according to the patient's blood glucose (sugar). Abasaglar can also be given together with diabetes medicines taken by mouth in patients who have type 2 diabetes.Patients can inject themselves with Abasaglar if they have been trained appropriately.For more information about using Abasaglar, see the package leaflet or contact your doctor or pharmacist.

How does Abasaglar work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Abasaglar is a replacement insulin that acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.Insulin glargine is slightly different from human insulin. The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.

What benefits of Abasaglar have been shown in studies?

Laboratory studies comparing Abasaglar with Lantus have shown that the active substance inAbasaglar is highly similar to that in Lantus in terms of structure, purity and biological activity. Studies have also shown that giving Abasaglar produces similar levels of the active substance in the body to giving Lantus. In addition, treatment with once-daily Abasaglar has been shown to be comparable to the reference medicine, Lantus, in two supportive studies involving a total of 1,295 adults with diabetes. In both studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes. Their average HbA1c before treatment was 7.8% and the average fall after 6 months was similar (it fell by 0.35 percentage points in the Abasaglar group and 0.46 percentage points in the Lantus group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus achieved HbA1c below the target of 7%.In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2 diabetes, as an addition to diabetes medicines taken by mouth. Average starting HbA1c was 8.3%, and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus, with an average percentage point fall of 1.29 and 1.34 respectively.Because Abasaglar is a biosimilar medicine, the studies on effectiveness and safety of insulin glargine carried out with Lantus do not all need to be repeated for Abasaglar

What are the risks associated with Abasaglar?

The safety of Abasaglar has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Lantus.The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) occur more often in children than in adults. For the full list of side effects and restrictions with Abasaglar, see the package leaflet.

Why is Abasaglar approved?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has a highly similar structure, purity and biological activity to Lantus and is distributed in the body in the same way. In addition, studies in patients with diabetes have shown that the safety and effectiveness of Abasaglar is equivalent to that of Lantus in this condition.All these data were considered sufficient to conclude that Abasaglar will behave in the same way as Lantus in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Lantus, the benefits of Abasaglar outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abasaglar?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abasaglar have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abasaglar are continuously monitored. Side effects reported with Abasaglar are carefully evaluated and any necessary action taken to protect patients.


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Abecma


What is Abecma and what is it used for?

Abecma is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has come back (relapsed) and has not responded to treatment (refractory). It is used in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and whose disease has worsened since the last treatment.Abecma is a type of advanced therapy medicine called 'gene therapy'. This type of medicine works by delivering genes into the body.Multiple myeloma is rare, and Abecma was designated an 'orphan medicine' (a medicine used in rare diseases) on 20 April 2017. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3171863 Abecma contains the active substance idecabtagene vicleucel.

How is Abecma used?

Abecma is prepared using the patient's own white blood cells which are extracted from the blood and genetically modified in the laboratory. Abecma can only be given to the patient whose cells were used to make the medicine.It is given as a single infusion (drip) into a vein. Before having Abecma, the patient should receive a short course of chemotherapy to clear away their existing white blood cells. Just before the infusion patients are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).Patients should be closely monitored for ten days after treatment for side effects and are advised to stay close to a specialist hospital for at least four weeks after treatment.For more information about using Abecma, see the package leaflet or contact your doctor or pharmacist.

How does Abecma work?

Abecma contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR). CAR can attach on the surface of cancer cells to a protein called B-cell maturation antigen (BCMA).When Abecma is given to the patient, the modified T cells attach to BCMA and then kill cancer cells, thereby helping to clear the cancer from the body.

What benefits of Abecma have been shown in studies?

A main study of 140 patients with multiple myeloma that was not responding to previous treatment (refractory myeloma) and had returned (relapsed myeloma) showed that Abecma is effective at clearing the cancer. Overall 30% had a complete response (which means they had no signs of the cancer left) and 67% had at least a partial response after treatment with Abecma.

What are the risks associated with Abecma?

The most common side effects (which may affect more than 1 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell), cytokine release syndrome (a potentially lifethreatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), anaemia (low red blood cell count), thrombocytopenia (low platelet counts), infections, leucopenia (low white blood cell count), tiredness, diarrhoea, hypokalaemia (low blood potassium levels), hypophosphataemia (low blood phosphate levels), nausea (feeling sick), lymphopenia (low levels of lymphocytes), fever, cough, hypocalcaemia (low blood levels of calcium), headache, hypomagnesaemia (low blood levels of magnesium), upper respiratory tract infection (nose and throat infection), joint pain, peripheral oedema (swelling especially of the ankles and feet), decreased appetite, hypogammaglobulinaemia (low levels of immunoglobulins) and febrile neutropenia (low blood levels of neutrophils with fever).The most common serious side effects include cytokine release syndrome (17%), pneumonia (7%), febrile neutropenia (6%) and fever (6%).People who cannot have chemotherapy to clear away their existing white blood cells (as per the package leaflet of the relevant chemotherapy) must not receive Abecma.For the full list of side effects and restrictions with Abecma, see the package leaflet.

Why is Abecma authorised in the EU?

Abecma led to clinically meaningful response rates in patients with multiple myeloma when the cancer had relapsed and not responded to treatment. Serious side effects, particularly cytokine release syndrome, can occur; however, these are manageable if appropriate measures are in place (see below). The European Medicines Agency decided that Abecma's benefits are greater than its risks and it can be authorised for use in the EU.Abecma has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Abecma?

Since Abecma has been given conditional authorisation, the company that markets Abecma will provide 24 months follow-up data on patients from the main study. In addition the company will carry out a study to compare Abecma with standard chemotherapy in people with relapsed and refractory multiple myeloma.

What measures are being taken to ensure the safe and effective use of Abecma?

The company that markets Abecma must:• ensure that hospitals where the medicine is given have appropriate expertise, facilities and training. Tocilizumab must be available in case of cytokine release syndrome.• provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome.The company must also carry out a study to obtain more information on the long term safety of Abecma.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abecma have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abecma are continuously monitored. Suspected side effects reported with Abecma are carefully evaluated and any necessary action taken to protect patients.


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Abevmy


What is Abevmy and what is it used for?

Abevmy is a cancer medicine that is used to treat adults with the following cancers:• cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;• breast cancer that has spread to other parts of the body;• a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Abevmy can be used in non-small cell lung cancer unless the cancer originates in cells called squamous cells;• cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;• cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb, and the peritoneum, the membrane that lines the abdomen) that is advanced or has come back after treatment;• cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or has spread to other parts of the body.Abevmy is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.Abevmy is a 'biosimilar medicine'. This means that Abevmy is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Abevmy is Avastin. For more information on biosimilar medicines, see here.Abevmy contains the active substance bevacizumab.

How is Abevmy used?

Abevmy can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.Abevmy is given by infusion (drip) into a vein. The first infusion of Abevmy should last 90 minutes, but subsequent infusions may be given more quickly if side effects with the earlier infusion wereacceptable. The dose depends on the patient's weight, the type of cancer being treated and the other cancer medicines being used. Treatment is continued for as long as the patient benefits from it. The doctor may interrupt or stop treatment if the patient develops certain side effects.For more information about using Abevmy, see the package leaflet or contact your doctor or pharmacist.

How does Abevmy work?

The active substance in Abevmy, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes new blood vessels grow. By attaching to VEGF, Abevmy stops its effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.

What benefits of Abevmy have been shown in studies?

Laboratory studies comparing Abevmy with Avastin have shown that the active substance in Abevmy is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Abevmy produces similar levels of the active substance in the body to giving Avastin.In addition, a study involving 671 patients with advanced non-small cell lung cancer showed thatAbevmy was as effective as Avastin when given with the cancer medicines paclitaxel and carboplatin. After 18 weeks the cancer had responded to treatment in 42% of those given Abevmy and 43% of those given Avastin, which was considered comparable.Because Abevmy is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Abevmy.

What are the risks associated with Abevmy?

The safety of Abevmy has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Avastin.The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Abevmy, see the package leaflet.Abevmy must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant (genetically engineered) antibodies. It must not be given to pregnant women.

Why is Abevmy authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Abevmy has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way. In addition, studies in non-small cell lung cancer have shown that the safety and effectiveness of Abevmy is equivalent to that of Avastin in this indication.All these data were considered sufficient to conclude that Abevmy will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Avastin, the benefits of Abevmy outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abevmy?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abevmy have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abevmy are continuously monitored. Side effects reported with Abevmy are carefully evaluated and any necessary action taken to protect patients.


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Abilify


What is Abilify and what is it used for?

Abilify is an antipsychotic medicine for patients with schizophrenia and bipolar I disorder.In schizophrenia, a mental illness with symptoms such as delusions, disorganised speech, and hallucinations (hearing or seeing things that are not there), Abilify is used to treat patients from the age of 15 years.In bipolar I disorder, Abilify is used in adults to treat manic episodes (periods of abnormally high mood) and to prevent new ones in those who have responded to the medicine in the past. It can also be used for up to 12 weeks to treat manic episodes in adolescents from the age of 13 years.Abilify contains the active substance aripiprazole.

How is Abilify used?

Abilify is available as tablets and a liquid to be taken by mouth. It is also available as a solution for injection into the shoulder or buttock muscle. The injection is used only for quickly controlling agitation or disturbed behaviour in patients with schizophrenia or bipolar I disorder. For information on the dose and dose adjustments, see the package leaflet.Abilify can only be obtained with a prescription.

How does Abilify work?

The active substance in Abilify is aripiprazole. The exact way it works is not known but it attaches in the brain to receptors for two substances (neurotransmitters) called dopamine and serotonin (5HT), which are believed to play a role in schizophrenia and bipolar disorder. By attaching to these receptors, it is thought that aripiprazole helps normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.

What benefits of Abilify have been shown in studies?

SchizophreniaStudies showed that Abilify is effective at treating symptoms of schizophrenia using standard rating scales (such as the Positive and Negative Syndrome Scale, PANSS).In studies of 1,203 adults, Abilify was more effective than placebo (a dummy treatment) at reducing symptoms. In another adult study, Abilify was as effective as haloperidol, another antipsychotic medicine, in preventing symptoms from returning over 1 year.Abilify has also been studied in 302 adolescents aged between 13 and 17, with results showing Abilify to be more effective than placebo.A study in 544 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify over 24 hours was greater than with placebo and similar to that with haloperidol.Bipolar I disorderStudies in bipolar I disorder showed that Abilify is effective at treating manic episodes using standard measurements such as the Young-Mania Rating Scale (YMRS) scale.In 4 out of 5 studies in 1,900 adults, Abilify was more effective than placebo at reducing manic symptoms, with two of these studies showing that Abilify has a similar effect to haloperidol and to lithium. Other studies showed that Abilify was more effective than placebo at preventing manic episodes in previously treated adults for up to 74 weeks, and when it was used as an add-on to existing treatment.A study in 296 children and adolescents showed that Abilify was more effective than placebo at reducing the manic symptoms in patients aged 13 years and older.Finally, a study in 291 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify was greater after 2 hours than with placebo and similar to that with lorazepam (another medicine for treating agitation).

What is the risk associated with Abilify?

In adults, the most common side effects when taking Abilify by mouth (occurring in up to 10 patients in 100) are restlessness, difficulty sleeping, anxiety, extrapyramidal disorder (uncontrolled twitching or jerking), akathisia (a constant urge to move), tremor (shaking), dizziness, sleepiness, headache, blurred vision, dyspepsia (heartburn), vomiting, nausea (feeling sick), constipation, salivary hypersecretion (increased production of saliva), tiredness and diabetes. The side effects are similar in adolescents, but sleepiness, extrapyramidal disorder, akathisia and tiredness are very common in this group (in more than 1 in 10 adolescents).AbilifyThe most common side effects with the injection (occurring in up to 10 patients in 100) are sleepiness, dizziness and nausea. For the full list of all side effects and restrictions, see the package leaflet.

Why is Abilify approved?

Studies comparing Abilify to placebo or other medicines (such as haloperidol and lithium) show that Abilify is effective at reducing symptoms of schizophrenia and at treating and preventing high moods in patients with bipolar I disorder.In addition, the injection has been shown to be effective at quickly controlling agitation or disturbing behaviour in patients with schizophrenia or bipolar I disorder.With regard to safety, the medicine has side effects comparable to those of other antipsychotics. The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that the benefits of Abilify are greater than its risks and recommended its approval in the EU.

What measures are being taken to ensure the safe and effective use of Abilify?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abilify have been included in the summary of product characteristics and the package leaflet.


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Abilify Maintena


What is Abilify Maintena and what is it used for?

Abilify Maintena is an antipsychotic medicine that contains the active substance aripiprazole. It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised with aripiprazole taken by mouth.Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).

How is Abilify Maintena used?

Abilify Maintena is available as a powder and solvent to be made into a prolonged-release suspension for injection. 'Prolonged release' means that the active substance is released slowly over a few weeks after being injected. The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse. It must not be injected into a vein or under the skin.The recommended dose depends on whether the patient is taking other medicines that slow the breakdown of aripiprazole in the body and may be reduced if the patient experiences side effects. Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided. The first treatment consists of either one injection followed by aripiprazole taken by mouth daily for 2 weeks or two injections and a single dose of aripiprazole by mouth on the same day.The medicine can only be obtained with a prescription.

How does Abilify Maintena work?

The active substance in Abilify Maintena is aripiprazole. The exact way it works is not known but it attaches to receptors in the brain for two substances (neurotransmitters) called dopamine and serotonin, which are believed to play a role in schizophrenia. By attaching to these receptors, it is thought that aripiprazole helps normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.

What benefits of Abilify Maintena have been shown in studies?

Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning. In one main study involving adults whose disease had already been stabilised with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.

What are the risks associated with Abilify Maintena?

The most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain. For the full list of all side effects reported with Abilify Maintena, see the package leaflet.

Why is Abilify Maintena authorised in the EU?

Abilify Maintena is as effective as aripiprazole taken by mouth and has a similar safety profile with the exception of injection pain, which was considered manageable. The monthly administration may help patients adhere to their treatment. The European Medicines Agency therefore decided that Abilify Maintena's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abilify Maintena?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abilify Maintena have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abilify Maintena are continuously monitored. Side effects reported with Abilify Maintena are carefully evaluated and any necessary action taken to protect patients.


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Abiraterone Accord


What is Abiraterone Accord and what is it used for?

Abiraterone Accord is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic).Abiraterone Accord is used together with prednisone or prednisolone (anti-inflammatory medicines):• when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Accord is then used in combination with a treatment called androgen deprivation therapy;• when medical castration (using medicines to stop the production of male hormones) with an androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);• when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.Abiraterone Accord contains the active substance abiraterone acetate and is a 'generic medicine'. This means that Abiraterone Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Zytiga. For more information on generic medicines, see the question-and-answer document here.

How is Abiraterone Accord used?

Abiraterone Accord is available as tablets and can only be obtained with a prescription. The recommended dose is 1,000 mg taken once a day on an empty stomach. This means that the patient should wait at least 2 hours after eating before taking the medicine and he must not eat for at least 1 hour after taking the medicine. If patients develop liver problems, treatment should be stopped.Treatment may be resumed at a reduced dose if liver function returns to normal.For more information about using Abiraterone Accord, see the package leaflet or contact your doctor or pharmacist.

How does Abiraterone Accord work?

The active substance in Abiraterone Accord, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Abiraterone Accord may slow the growth of the prostate cancer.

How has Abiraterone Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zytiga, and do not need to be repeated for Abiraterone Accord.As for every medicine, the company provided studies on the quality of Abiraterone Accord. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Abiraterone Accord?

Because Abiraterone Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Abiraterone Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, AbirateroneAccord has been shown to have comparable quality and to be bioequivalent to Zytiga. Therefore, the Agency's view was that, as for Zytiga, the benefits of Abiraterone Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abiraterone Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abiraterone Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abiraterone Accord are continuously monitored. Side effects reported with Abiraterone Accord are carefully evaluated and any necessary action taken to protect patients.


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Abiraterone Krka


What is Abiraterone Krka and what is it used for?

Abiraterone Krka is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic).Abiraterone Krka is used together with prednisone or prednisolone (anti-inflammatory medicines):• when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Krka is then used in combination with a treatment called androgen deprivation therapy;• when medical castration (using medicines to stop the production of male hormones) with androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);• when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.Abiraterone Krka contains the active substance abiraterone acetate and is a 'generic medicine'. This means that Abiraterone Krka contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Zytiga. For more information on generic medicines, see the question-and-answer document here.

How is Abiraterone Krka used?

Abiraterone Krka is available as tablets and can only be obtained with a prescription. The recommended dose is 1,000 mg taken once a day on an empty stomach. This means that the patient should wait at least 2 hours after eating before taking the medicine and must not eat for at least 1 hour after taking the medicine. If patients develop liver problems, treatment should be stopped.Treatment may be resumed at a reduced dose if liver function returns to normal.For more information about using Abiraterone Krka, see the package leaflet or contact your doctor or pharmacist.Send

How does Abiraterone Krka work?

The active substance in Abiraterone Krka, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Abiraterone Krka may slow the growth of the prostate cancer.

How has Abiraterone Krka been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zytiga, and do not need to be repeated for Abiraterone Krka.As for every medicine, the company provided studies on the quality of Abiraterone Krka. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Abiraterone Krka?

Because Abiraterone Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Abiraterone Krka authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Abiraterone Krka has been shown to have comparable quality and to be bioequivalent to Zytiga. Therefore, the Agency's view was that, as for Zytiga, the benefits of Abiraterone Krka outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abiraterone Krka?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abiraterone Krka have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abiraterone Krka are continuously monitored. Side effects reported with Abiraterone Krka are carefully evaluated and any necessary action taken to protect patients.


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Abiraterone Mylan


What is Abiraterone Mylan and what is it used for?

Abiraterone Mylan is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic).Abiraterone Mylan is used together with prednisone or prednisolone (anti-inflammatory medicines):• when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Mylan is then used in combination with a treatment called androgen deprivation therapy;• when medical castration (using medicines to stop the production of male hormones) with androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);• when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.Abiraterone Mylan contains the active substance abiraterone acetate and is a 'generic medicine'. This means that Abiraterone Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Zytiga. For more information on generic medicines, see the question-and-answer document here.

How is Abiraterone Mylan used?

Abiraterone Mylan is available as tablets and can only be obtained with a prescription. The recommended dose is 1,000 mg taken once a day on an empty stomach. This means that the patient should wait at least two hours after eating before taking the medicine and must not eat for at least one hour after taking the medicine. If the patient develops liver problems, treatment should be stopped.Treatment may be resumed at a reduced dose if the liver function returns to normal.For more information about using Abiraterone Mylan, see the package leaflet or contact your doctor or pharmacist.Send

How does Abiraterone Mylan work?

The active substance in Abiraterone Mylan, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Abiraterone Mylan can slow the growth of the prostate cancer.

How has Abiraterone Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zytiga, and do not need to be repeated for Abiraterone Mylan.As for every medicine, the company provided data on the quality of Abiraterone Mylan. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Abiraterone Mylan?

Because Abiraterone Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Abiraterone Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, AbirateroneMylan has been shown to have comparable quality and to be bioequivalent to Zytiga. Therefore, the Agency's view was that, as for Zytiga, the benefits of Abiraterone Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abiraterone Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abiraterone Mylan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abiraterone Mylan are continuously monitored. Side effects reported with Abiraterone Mylan are carefully evaluated and any necessary action taken to protect patients.


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Abraxane


What is Abraxane?

Abraxane is a powder that is made up into a suspension for infusion (drip) into a vein. It contains the active substance paclitaxel attached to a human protein called albumin.

What is Abraxane used for?

Abraxane is used to treat the following cancers in adults:• metastatic breast cancer, when the first treatment has stopped working and standard treatment including an 'anthracycline' (another type of cancer medicine) is not suitable. 'Metastatic' means that the cancer has spread to other parts of the body.• metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine.• non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.The medicine can only be obtained with a prescription.

How is Abraxane used?

Abraxane should only be given under the supervision of a specialist cancer doctor in units that are specialised in giving 'cytotoxic' (cell-killing) medicines. It should not be interchanged with other medicines containing paclitaxel.Abraxane is given into a vein over a period of 30 minutes.In metastatic breast cancer Abraxane is given on its own every three weeks. The recommended dose is 260 mg per square metre of body surface area (calculated using the patient's height and weight).In metastatic adenocarcinoma of the pancreas Abraxane is given in 4-week treatment cycles. The recommended dose is 125 mg per square metre of body surface area once a day on days 1, 8 and 15 of each cycle. Immediately after giving Abraxane gemcitabine should be given at a dose of 1000 mg per square metre of body surface area.In non-small cell lung cancer, treatment is carried out in 3-week cycles with Abraxane given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Abraxane. The recommended dose of Abraxane is 100 mg per square metre of body surface area.For additional information, see the summary of product characteristics (also part of the EPAR).

How does Abraxane work?

The active substance in Abraxane, paclitaxel, belongs to the group of cancer medicines known as the 'taxanes'. Paclitaxel blocks a stage of cell division in which the cell's internal 'skeleton' is dismantled to allow the cell to divide. By keeping this structure intact the cells cannot divide and they eventually die. Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.Paclitaxel has been available as a cancer medicine since 1993. In Abraxane, unlike conventional paclitaxel-containing medicines, the paclitaxel is attached to a human protein called albumin in tiny particles known as 'nanoparticles'. This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.

How has Abraxane been studied?

For metastatic breast cancer, Abraxane has been studied in one main study involving 460 women, around three-quarters of whom had received an anthracycline in the past. Around half of the patients in the study had already received treatments for their cancer after it had become metastatic. Abraxane given on its own was compared with a conventional paclitaxel-containing medicine given together with other medicines to reduce side effects. The main measure of effectiveness was the number of patients who 'responded' after at least five weeks of treatment. A response was defined as the patient's main tumours disappearing or shrinking in size by at least 30%.For metastatic adenocarcinoma of the pancreas, Abraxane was studied in one main study involving 861 patients who received either Abraxane in combination with gemcitabine or gemcitabine alone. The main measure of effectiveness was how long patients lived.For non-small cell lung cancer, the Abraxane-carboplatin combination was compared with a combination of a conventional paclitaxel-containing medicine and carboplatin in 1,052 patients. The main measure of effectiveness was the percentage of patients who responded to treatment.

What benefit has Abraxane shown during the studies?

In metastatic breast cancer, Abraxane was more effective than conventional paclitaxel-containing medicines. Overall, in the main study, 31% of the women receiving Abraxane responded to treatment (72 out of 229), compared with 16% of the women receiving conventional paclitaxel-containing medicines (37 out of 225).When looking only at the patients who were receiving their first treatment for metastatic breast cancer, there was no difference between the medicines in terms of measures of effectiveness such as the time until the disease got worse and survival. In contrast, Abraxane was more effective than conventional paclitaxel-containing medicines in patients who had taken other treatments for metastatic breast cancer before. Therefore, the company withdrew its application for the use of Abraxane as firstline treatment during the assessment of the medicine.In metastatic adenocarcinoma of the pancreas, Abraxane was shown to improve overall survival. Patients survived for around 8.5 months on treatment with the combination of Abraxane and gemcitabine, compared with 6.7 months on gemcitabine alone.In non-small cell lung cancer, 33% of patients receiving Abraxane and carboplatin responded to treatment compared with 25% of those receiving conventional paclitaxel and carboplatin.

What is the risk associated with Abraxane?

The most common important side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cells), gastrointestinal disorders (disorders of the digestive system), peripheral neuropathy (nerve damage including damage to the nerves in the hand and feet), arthralgia (joint pain) and myalgia (muscle pain). For the full list of all side effects reported with Abraxane, see the package leaflet.Abraxane must not be used in patients who are breast-feeding or who have low levels of neutrophils in the blood before starting treatment. For the full list of restrictions with Abraxane, see the package leaflet.

Why has Abraxane been approved?

The CHMP noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients with metastatic breast cancer whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, patients to be treated with Abraxane do not need pre-treatment with other medicines to prevent hypersensitivity reactions. In addition, Abraxane given in combination with gemcitabine was shown to improve survival in patients with metastatic adenocarcinoma of the pancreas compared with treatment with gemcitabine alone and was effective in combination with carboplatin in the treatment non-small cell lung cancer. The Committee decided that Abraxane's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Abraxane?

A risk management plan has been developed to ensure that Abraxane is used as safely and effectively as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abraxane, including the appropriate precautions to be followed by healthcare professionals and patients.


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Abrysvo


What is Abrysvo and what is it used for?

Abrysvo is a vaccine for protecting against lower respiratory tract disease (LRTD; diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.It is also for use in mothers during pregnancy to protect their infants against LRTD from birth through 6 months of age.Abrysvo contains versions of two proteins found on the surface of the virus called RSV subgroup A stabilised prefusion F and RSV subgroup B stabilised prefusion F.

How is Abrysvo used?

The recommended dose is one single injection into the muscle of the upper arm. Pregnant individuals should receive the dose between weeks 24 and 36 of gestation.The vaccine can only be obtained with a prescription and should be used according to official recommendations issued at national level by public health bodies. For more information about using Abrysvo, see the package leaflet or contact your doctor or pharmacist.

How does Abrysvo work?

Abrysvo works by 'teaching' the immune system (the body's natural defences) how to defend the body against a disease. Abrysvo contains proteins from the surface of the RSV virus. When a person is given the vaccine, the immune system treats the viral proteins as 'foreign' and makes defences against them. If, later on, the vaccinated person comes into contact with the virus, the immune system will recognise the viral proteins and be prepared to attack it. This will help to protect against LRTD caused by the virus.

What benefits of Abrysvo have been shown in studies?

In a study in over 34,000 adults aged 60 years and above, people who received Abrysvo had a 67% reduction in their risk of getting LRTD caused by RSV compared with those who had a dummy injection. Of the 16,306 adults who received the vaccine, 11 developed severe RSV-LRTD, defined as LRTD with at least two or more lower respiratory symptoms of RSV, compared with 33 adults out of the 16,308 who received the dummy injection. In addition, 2 of those who received Abrysvo developed three or more symptoms of RSV-LRTD compared with 14 adults who received the dummy injection.A second study in pregnant women showed that Abrysvo reduced the risk of RSV-LRTD by 51% in infants born to vaccinated mothers compared with those whose mothers received a dummy injection. Of 3,495 infants born to mothers vaccinated with Abrysvo, 57 developed RSV-LRTD within the first 6 months after birth, compared with 117 out of the 3,480 infants born to mothers who had a dummy injection.

What are the risks associated with Abrysvo?

For the full list of side effects and restrictions with Abrysvo, see the package leaflet.The most common side effects (which may affect more than 1 in 10 people) with Abrysvo in people aged 60 years and above include pain at the vaccination site.The most common side effects (which may affect more than 1 in 10 people) with Abrysvo in pregnant women at 24 to 36 weeks of gestation include pain at the vaccination site, headache and myalgia (muscle pain).The majority of side effects were mild to moderate and resolved within a few days.

Why is Abrysvo authorised in the EU?

Abrysvo was shown to be effective at preventing RSV-LRTD in adults aged from 60 years as well as in infants born to vaccinated mothers for at least the first 6 months of life. There are no major safety concerns and the majority of side effects with Abrysvo were mild or moderate. The European Medicines Agency therefore decided that Abrysvo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Abrysvo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abrysvo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Abrysvo are continuously monitored. Suspected side effects reported with Abrysvo are carefully evaluated and any necessary action taken to protect patients.


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Abseamed


What is Abseamed?

Abseamed is a solution for injection. It is available in pre-filled syringes that contain between 1,000 and 40,000 international units (IU) of the active substance, epoetin alfa.Abseamed is a 'biosimilar' medicine. This means that Abseamed is similar to and contains the same active substance as a biological medicine that is already authorised in the European Union (EU), which is known as the 'reference medicine'. The reference medicine for Abseamed is Eprex/Erypo. For more information on biosimilar medicines, see the question-and-answer document here.

What is Abseamed used for?

Abseamed is used for the following:• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with 'chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;• to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);•The medicine can only be obtained with a prescription.

How is Abseamed used?

Treatment with Abseamed must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for. The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.Abseamed is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated. The injection under the skin may be given by the patient or their carer if they have been appropriately trained. The dose, the frequency of injection and how long it is used for also depend on why Abseamed is being used and on the patient's bodyweight, and are adjusted according to the patient's response.For patients with chronic kidney failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children). Haemoglobin is the protein in red blood cells that carries oxygen around the body. For these patients, the lowest dose that provides adequate control of symptoms should be used.For full details, see the summary of product characteristics (also part of the EPAR).

How does Abseamed work?

The active substance in Abseamed, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells from the bone marrow. Erythropoietin is produced by the kidneys. In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally. In these cases, epoetin alfa is used to replace the missing hormone or to increase red blood cell counts. Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.

How has Abseamed been studied?

Abseamed was studied to show that it is comparable to the reference medicine, Eprex/Erypo.Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems. All of the patients had been receivingEprex/Erypo injected into a vein for at least eight weeks before they were either switched to Abseamed or remained on Eprex/Erypo. The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29. The company also presented the results of a study comparing the effects of Abseamed injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.A further study looked at the effects of Abseamed given under the skin in 416 patients with chronic kidney failure.

What benefit has Abseamed shown during the studies?

Abseamed was as effective as Eprex/Erypo in increasing and maintaining red blood cell counts.In the study of patients with anaemia caused by kidney problems, patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo. The study in patients receiving chemotherapy showed that Abseamed was also as effective as Eprex/Erypo when it was injected under the skin.The study in patients with chronic kidney failure showed that Abseamed was safe and effective when given under the skin.

What is the risk associated with Abseamed?

The most common side effects with Abseamed (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache. Flu-like illness may occur especially at the start of treatment. For the full list of all side effects reported with Abseamed, see the package leaflet.Abseamed must not be used in the following groups:• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin;• patients with high blood pressure that is not controlled;• patients undergoing surgery who cannot receive medicines for the prevention of blood clots.• When Abseamed is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.• It must also not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.For the full list of restrictions, see the package leaflet.

Why has Abseamed been approved?

The CHMP concluded that, in accordance with EU requirements, Abseamed has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo. Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks. The Committee recommended that Abseamed be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Abseamed?

A risk management plan has been developed to ensure that Abseamed is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abseamed, including the appropriate precautions to be followed by healthcare professionals and patients.


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Accofil


What is Accofil and what is it used for?

Accofil is a medicine that is used to stimulate the production of white blood cells in the following situations:• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving cytotoxic chemotherapy (medicines to treat cancer by killing cells);• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;• to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;• to treat persistent neutropenia in patients with advanced Human-Immunodeficiency-Virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.Accofil, which contains the active substance filgrastim, is a 'biosimilar medicine'. This means that Accofil is similar to a biological medicine (also known as the 'reference medicine') that is already authorised in the European Union (EU). The reference medicine for Accofil is Neupogen. For more information on biosimilar medicines, see the question-and-answer document here.

How is Accofil used?

Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes. It is given by injection under the skin or infusion into a vein. It can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.The way Accofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment. More information can be found in the summary of product characteristics (also part of the EPAR).

How does Accofil work?

The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells. The filgrastim in Accofil is produced by a method known as 'recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce filgrastim.

What benefits of Accofil have been shown in studies?

Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia. Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Accofil the next day and daily for up to 14 days. The main measure of effectiveness was the duration of severe neutropenia. Severe neutropenia lasted on average for 1.4 days. This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim. Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.

What are the risks associated with Accofil?

The most common side effect with Accofil (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Accofil is being used for. For the full list of all side effects and restrictions reported with Accofil, see the package leaflet.

Why is Accofil approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Accofil?

A risk management plan has been developed to ensure that Accofil is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Accofil, including the appropriate precautions to be followed by healthcare professionals and patients.


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Aclasta


What is Aclasta?

Aclasta is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid.

What is Aclasta used for?

Aclasta is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men. It is used in patients who are at risk of fractures (broken bones) including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).Aclasta is also used to treat Paget's disease of the bone in adults. This is a disease where the normal process of bone growth is changed.The medicine can only be obtained with a prescription.

How is Aclasta used?

Aclasta is given as an infusion lasting at least 15 minutes. This can be repeated once a year in patients being treated for osteoporosis. Patients who have broken their hip should not receive Aclasta any earlier than two weeks after the operation to repair the fracture. For Paget's disease, only one infusion of Aclasta is usually given, but additional infusions can be considered if the patient's disease comes back. The effect of each infusion lasts for a year or more.Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium. Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion. In the treatment of Paget's disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease.Aclasta should not be used in patients with severe kidney problems.

How does Aclasta work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to fracture. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall. Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment. In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.The active substance in Aclasta, zoledronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss in osteoporosis and less disease activity in Paget's disease. Zoledronic acid has also been authorised in the European Union (EU) as Zometa since March 2001 for the prevention of bone complications in patients with cancer that is affecting the bone, and for the treatment of hypercalcaemia (high blood calcium levels) caused by tumours.

How has Aclasta been studied?

Because zoledronic acid has been authorised in the EU as Zometa for a number of years, the company presented the results of some studies carried out with Zometa, which were taken into account when assessing Aclasta.For osteoporosis, Aclasta has been studied in three main studies. The first compared Aclasta with placebo (a dummy treatment) in almost 8,000 elderly women with osteoporosis, looking at the number of fractures in the spine and the hip over three years. The second study compared Aclasta with placebo in 2,127 men and women with osteoporosis who had recently broken their hip, and looked at the number of fractures over up to five years. The third compared one infusion of Aclasta with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, and looked at the change in the density of the bones in the spine over a year. In these studies, the patients could take other medicines for osteoporosis, but not other bisphosphonates.For Paget's disease, Aclasta has been compared with risedronate in a total of 357 adults in two studies lasting six months. The patients received one infusion of Aclasta or they took risedronate once a day for two months. The main measure of effectiveness was the number of patients who responded to treatment, defined as blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returning to normal or falling at least three-quarters of the way back to normal.

What benefit has Aclasta shown during the studies?

In osteoporosis, Aclasta was more effective than the comparator medicines. In the study of elderly women, the risk of fractures in the spine was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years when compared with those taking placebo. There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo. In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with13% of the patients receiving placebo (139 out of 1,062). Finally, Aclasta was more effective than risedronate at increasing spine bone density over a year's treatment in patients taking glucocorticoids.In Paget's disease, Aclasta was more effective than risedronate. After six months, around 96% of patients had responded to treatment in the two studies, compared with around 74% of the patients who received risedronate.

What is the risk associated with Aclasta?

Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions. The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever. Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported rarely (seen in between 1 and 10 patients in 10,000). For the full list of all side effects reported with Aclasta, see the package leaflet.Aclasta must not be used in people who are hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients. Aclasta must not be used in patients with severe kidney problems, hypocalcaemia (low blood calcium levels), or in pregnant or breastfeeding women.

Why has Aclasta been approved?

The CHMP decided that Aclasta's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Aclasta?

A risk management plan has been developed to ensure that Aclasta is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aclasta, including the appropriate precautions to be followed by healthcare professionals and patients.The company that makes Aclasta will provide educational packs in each Member State for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used. It will also provide an information pack for patients to explain the medicine's side effects, remind them of the need for adequate calcium and vitamin D supplementation, and when patients should contact their doctor. Patients will also be provided with a reminder card on the risk of osteonecrosis of the jaw, instructing patients to contact their doctor if they experience symptoms.


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Actelsar Hct


What is Actelsar HCT and what is it used for?

Actelsar HCT is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. 'Essential' means that the hypertension has no obvious cause.Actelsar HCT is a 'generic medicine'. This means that Actelsar HCT is similar to a 'reference medicine' already authorised in the European Union (EU) called MicardisPlus. For more information on generic medicines, see the question-and-answer document here.

How is Actelsar HCT used?

Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid. The dose of Actelsar HCT to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets. The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Actelsar HCT.The medicine can only be obtained with a prescription.

How does Actelsar HCT work?

Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide.Telmisartan is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has Actelsar HCT been studied?

Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Actelsar HCT?

Because Actelsar HCT is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Actelsar HCT approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus. Therefore, the CHMP's view was that, as for MicardisPlus, the benefit outweighs the identified risk. The Committee recommended that Actelsar HCT be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Actelsar HCT?

Safety information has been included in the summary of product characteristics and the package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients.


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Actos


What is Actos?

Actos is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).

What is Actos used for?

Actos is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is used in addition to diet and exercise as follows:• on its own in patients for whom metformin (another diabetes medicine) is not suitable;• in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;• together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;• together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.The medicine can only be obtained with a prescription.

How is Actos used?

The recommended starting dose of Actos is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. The tablets should be swallowed with water.Treatment with Actos should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

How does Actos work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Actos, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.

How has Actos been studied?

Actos has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies. Some studies also looked at combining Actos with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea. Further studies also looked at long-term use of Actos. Almost 7,000 patients received Actos in all of the studies combined. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

What benefit has Actos shown during the studies?

Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Actos on its own was shown to be as effective as metformin and gliclazide. Actos also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.

What is the risk associated with Actos?

The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight. If Actos is used in combination with other diabetes medicines, other side effects may occur. For the full list of all side effects reported with Actos, see the package leaflet.Actos must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes). It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated. For the full list of restrictions, see the package leaflet.

Why has Actos been approved?

The CHMP decided that Actos's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Actos?

The company that markets Actos will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Actos have also been included in the summary of product characteristics and the package leaflet.


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Actraphane


What is Actraphane?

Actraphane is a suspension for injection that contains the active substance human insulin. It is available as vials, cartridges (Penfill) or prefilled pens (InnoLet or FlexPen). Actraphane contains both fast-acting (soluble) and long-acting (isophane) insulin:• Actraphane 30: soluble insulin 30% and isophane insulin 70%;• Actraphane 40: soluble insulin 40% and isophane insulin 60%;• Actraphane 50: soluble insulin 50% and isophane insulin 50%.

What is Actraphane used for?

Actraphane is used to treat diabetes.The medicine can only be obtained with a prescription.

How is Actraphane used?

Actraphane is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder). The injection site should be changed for each injection. The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day. Actraphane is given 30 minutes before a meal. It is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.

How does Actraphane work?

Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or when the body is unable to use insulin effectively. Actraphane is a replacement insulin which is very similar to the insulin made by the pancreas.The active substance in Actraphane, human insulin, is produced by a method known as 'recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin. Actraphane contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an isophane form, which is absorbed much more slowly during the day. This gives Actraphane a longer duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose, the symptoms and complications of diabetes are reduced.

How has Actraphane been studied?

Actraphane has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively. About onethird of the patients had type 1 diabetes and the remainder had type 2 diabetes. The study compared Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart). The study measured the level of glycosylated haemoglobin (HbA1c) after 12 weeks, which is the percentage of haemoglobin in the blood that has glucose attached. HbA1c gives an indication of how well the blood glucose is controlled.

What benefit has Actraphane shown during the studies?

Actraphane led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin. Actraphane was effective for both type 1 and type 2 diabetes.

What is the risk associated with Actraphane?

The most common side effect with Actraphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects and restrictions, see the package leaflet.

Why has Actraphane been approved?

The CHMP decided that Actraphane's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Actraphane?

A risk management plan has been developed to ensure that Actraphane is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Actraphane, including the appropriate precautions to be followed by healthcare professionals and patients.


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Actrapid


What is Actrapid?

Actrapid is a solution for injection that contains the active substance human insulin. It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).

What is Actrapid used for?

Actrapid is used to treat diabetes.The medicine can only be obtained with a prescription.

How is Actrapid used?

Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks). The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day. Actrapid is given 30 minutes before a meal. Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins. Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.

How does Actrapid work?

Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or when the body is unable to use insulin effectively. Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.The active substance in Actrapid, human insulin, is produced by a method known as 'recombinant technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose, the symptoms and complications of diabetes are reduced.

How has Actrapid been studied?

Actrapid has been studied in patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type 2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients). The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached. HbA1c gives an indication of how well the blood glucose is controlled.

What benefit has Actrapid shown during the studies?

HbA1c levels remained fairly steady over the six months of treatment with Actrapid.

What is the risk associated with Actrapid?

The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full description of all side effects reported with Actrapid, see the package leaflet.Actrapid must not be used in people who are hypersensitive to human insulin or any of the other ingredients.

Why has Actrapid been approved?

The CHMP decided that Actrapid's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Adasuve


What is Adasuve?

Adasuve is a medicine that contains the active substance loxapine. It is available as an inhalation powder in a portable inhaler device for single use (4.5 mg and 9.1 mg).

What is Adasuve used for?

Adasuve is used to rapidly control mild to moderate agitation in adults with schizophrenia or bipolar disorder. Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). Bipolar disorder is a mental illness with alternating periods of high mood and depression. Agitation is a known complication of both mental illnesses.The medicine can only be obtained with a prescription.

How is Adasuve used?

Adasuve should only be used in a hospital under the supervision of a healthcare professional. An airway-opening medicine called a short-acting beta agonist should also be available for the treatment of patients who develop bronchospasm (excessive and prolonged contraction of the airway muscles).Treatment with Adasuve is started with the inhalation of a single dose of 9.1 mg. If considered necessary the doctor may prescribe a second dose of 9.1 mg after two hours. A lower dose of 4.5 mg may be prescribed if the patient did not tolerate the initial dose of 9.1 mg or if a lower dose isconsidered more appropriate. Patients should be observed for signs of shortness of breath for one hour after each dose.Information on how to use the inhaler can be found in the package leaflet.

How does Adasuve work?

The active substance in Adasuve, loxapine, is an antipsychotic medicine. In the brain, it attaches to and blocks several different receptors on the surface of nerve cells. This disrupts signals transmitted between brain cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. Loxapine works mainly by blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in agitation in schizophrenia and bipolar disorder, loxapine helps to normalise the activity of the brain, reducing agitation. Its action on receptors for other neurotransmitters may also play a role.

How has Adasuve been studied?

The effects of Adasuve were first tested in experimental models before being studied in humans.Adasuve has been studied in two main studies. One study involved 344 patients with schizophrenia and the second study involved 314 patients with bipolar disorder. Both studies compared 4.5 mg and 9.1 mg of Adasuve with placebo (a dummy treatment).The main measure of effectiveness was the change in the patients' symptoms two hours after giving a dose of loxapine, assessed using a standard scale of agitation in patients with schizophrenia and bipolar disorder (positive and negative symptom scale, excited component: PEC score). A fall in PEC score indicates an improvement in symptoms.

What benefit has Adasuve shown during the studies?

Adasuve was more effective than placebo at controlling agitation. In the study in patients with schizophrenia, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.0 points and patients taking 9.1 mg had an average fall of 8.7 points. This compared with a fall of 5.8 points in patients taking placebo. The PEC score at the beginning of the study for these groups of patients was between 17 and 18.In the study in patients with bipolar disorder, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.2 points, and patients taking 9.1 mg had an average fall of 9.2 points. This compared with a fall of 4.7 points in patients taking placebo. The PEC score at the beginning of the study for these groups of patients was between 17 and 18.

What is the risk associated with Adasuve?

In studies in agitated patients, bronchospasm was reported as an uncommon but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short acting beta-agonist. The most common side effects with Adasuve are dysgeusia (taste disturbances), sedation or somnolence (sleepiness) and dizziness. For the full list of all side effects reported with Adasuve, see the package leaflet.Adasuve must not be used in people who are hypersensitive (allergic) to loxapine or any of the other ingredients. It must also not be used in patients with symptoms such as wheezing and shortness of breath or who have lung conditions such as asthma or chronic obstructive pulmonary disease.

Why has Adasuve been approved?

The CHMP concluded that Adasuve has been demonstrated to rapidly control (within minutes) mild to moderate agitation in patients with schizophrenia or bipolar disorder who are cooperative with using an inhaler. The CHMP noted that the administration of Adasuve is non-invasive. Regarding its safety, most side effects are comparable to those of other antipsychotic medicines. The potential risk of bronchospasm is considered manageable and has been adequately addressed through risk minimisation measures. The CHMP concluded that the benefits of Adasuve outweigh its risks and recommended that it be granted marketing authorisation.

What measures are being taken to ensure the safe use of Adasuve?

The company that makes Adasuve must ensure that all healthcare professionals who are expected to use Adasuve receive an information pack containing key information on how to use the medicine as well as important safety information.


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Adcetris


What is Adcetris and what is it used for?

Adcetris is a cancer medicine used to treat adults with certain lymphomas (cancers of lymphocytes, white blood cells that are part of the immune system). It is used when the cancer cells have a protein called CD30 on their surface (CD30-positive).For Hodgkin's lymphoma (HL), it is given:• together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in patients who have stage IV disease (advanced cancer that has spread outside the lymphatic system) that has not been treated before;• when the cancer has come back or has not responded to an autologous stem cell transplant (a transplant of the patient's own blood-producing cells);• if the cancer is likely to come back or get worse after an autologous stem cell transplant;• when the cancer has come back or has not responded to at least two other therapies and when autologous stem cell transplant or multi-agent chemotherapy (a combination of cancer medicines) cannot be used;In non-Hodgkin's lymphoma, Adcetris is used for:• systemic anaplastic large cell lymphoma (sALCL, a cancer of lymphocytes called T-cells) when the cancer has never been treated before; Adcetris is used together with cyclophosphamide, doxorubicin and prednisone. It is also used when the cancer has come back or when other treatments have not worked;• cutaneous T-cell lymphoma (CTCL), a lymphoma of T-cells that initially affects the skin, in patients who have received at least one previous treatment.These diseases are rare, and Adcetris was designated an 'orphan medicine' (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency's website (Hodgkin's lymphoma: 15 January 2009; cutaneous T-cell lymphoma: 11 January 2012; peripheral T-cell lymphoma: 21 August 2019).Adcetris contains the active substance brentuximab vedotin.Send

How is Adcetris used?

Adcetris can only be obtained with a prescription, and it should be given under the supervision of a doctor who has experience in the use of cancer treatments.The recommended dose depends on body weight and whether Adcetris is given with other cancer medicines. The medicine is given by a 30-minute infusion (drip) into a vein every 2 or 3 weeks. When given with other cancer medicines, patients may also be given a medicine to help prevent neutropenia (low white blood cell count). Patients should be monitored during and after the infusion for certain side effects and they should have full blood counts (tests of the number of blood cells) before every dose of Adcetris.The doctor may interrupt or stop treatment or reduce the dose if the patient develops certain serious side effects. For more information about using Adcetris, see the package leaflet or contact your doctor or pharmacist.

How does Adcetris work?

The active substance in Adcetris, brentuximab vedotin, is made up of a monoclonal antibody (a type of protein) that binds to CD30, linked to monomethyl auristatin E, a cytotoxic (cell-killing) molecule. The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells. The cytotoxic molecule then enters the cancer cells and stops them from dividing, and the cancer cells eventually die.

What benefits of Adcetris have been shown in studies?

Hodgkin's lymphomaIn a main study of 1,334 patients with CD30-positive HL who had not received previous treatment, Adcetris plus doxorubicin, vinblastine and dacarbazine was compared with bleomycin also given with doxorubicin, vinblastine and dacarbazine. After 2 years, 82% of patients given Adcetris lived without their disease getting worse, compared with 77% of patients given bleomycin.In another main study, Adcetris was used in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment. Response to treatment was assessed using body scans and patients' clinical data. A complete response is when a patient has no signs of cancer. In this study, the cancer responded partially or completely to treatment in 75% of patients (76 out of 102). A complete response occurred in 33% of patients (34 out of 102).In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least 2 prior therapies and who were not eligible for autologous stem cell transplant or multi-agent chemotherapy. The cancer responded to treatment in 55% of patients (22 out of 40). For 23% of these patients (9 out of 40) a complete response was observed.In another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back. The average time patients lived before their disease got worse was around 43 months in those given Adcetris, compared with around 24 months in those receiving placebo. The benefit was sustained during 3 years of follow-up.Systemic anaplastic large cell lymphomaAdcetris was studied in 452 patients with CD30+ peripheral T cell lymphomas (PTCL) of whom about 70% had sALCL. The patients had not been treated for their cancer before and received either Adcetris plus cyclophosphamide, doxorubicin and prednisone, or cyclophosphamide, doxorubicin, vincristine and prednisone. Patients with sALCL who were treated with Adcetris lived on average 56 months without their disease progressing compared with 54 months in the other group. In addition, after 2 years, 68% of patients given Adcetris lived without their disease getting worse, compared with 54% of patients in the other group. Since most patients in the study had sALCL and many other types of PTCL with different prognoses were not represented, it was considered that the effectiveness of Adcetris in the broader PTCL indication was not demonstrated.Adcetris was also studied in 58 sALCL patients whose cancer had come back or had not responded to treatment. In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and response was complete for 59% (34 out of 58).Cutaneous T-cell lymphomaAdcetris was effective in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment. The study compared treatment with Adcetris and treatment with another medicine (methotrexate or bexarotene). The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).

What are the risks associated with Adcetris?

The most common side effects of Adcetris (which may affect more than 1 in 10 people) are infections (including infections of the nose and throat), peripheral sensory or motor neuropathy (nerve damage that affects feeling or muscle control and co-ordination), tiredness, nausea (feeling sick), diarrhoea, fever, neutropenia (low levels of a type of white blood cell), rash, cough, vomiting, joint pain, infusionrelated reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain. For the full list of side effects with Adcetris, including side effects when used with other medicines, see the package leaflet.Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs. For the full list of all restrictions with Adcetris, see the package leaflet.

Why is Adcetris authorised in the EU?

The European Medicines Agency noted that, despite limited data and paucity of studies that compared Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy. In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a cure or could enable them to undergo potentially curative treatments. In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit. Previously untreated patients with advanced HL or with sALCL also benefited from Adcetris used in combination with other cancer medicines. In patients with CTCL, a clinically significant benefit was seen over treatment with bexarotene or methotrexate. The Agency further noted that the overall safety profile of Adcetris was acceptable given the serious conditions for which it is used. Therefore, the Agency decided that the benefits of Adcetris are greater than its risks and recommended that it be approved for use in the EU.Adcetris has been given 'conditional approval'. This means that there is more evidence to come, especially about the medicine's long-term effects, which are needed to confirm the positive benefit-risk balance. Every year, the Agency will review any new information that may become available and this overview will be updated as necessary.

What information is still awaited for Adcetris?

The company that markets the medicine will provide the results of a study on the benefits of the medicine in sALCL patients and of a safety study in a larger population of HL and sALCL patients.

What measures are being taken to ensure the safe and effective use of Adcetris?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcetris have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Adcetris are continuously monitored. Side effects reported with Adcetris are carefully evaluated and any necessary action taken to protect patients.


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Adcirca


What is Adcirca and what is it used for?

Adcirca is a medicine used to treat adults and children from 2 years of age with pulmonary arterial hypertension (PAH).PAH is a disease where there is abnormally high blood pressure in the arteries of the lungs. Adcirca is used in patients with PAH class II (where the patients have slight limitation of physical activity) and PAH class III (where patients have marked limitation of physical activity).Adcirca contains the active substance tadalafil.

How is Adcirca used?

Adcirca is available as tablets and as a liquid to be taken by mouth. Both can only be obtained with a prescription. Treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.The recommended dose for adults is 40 mg once a day. For children the dose depends on the child's weight. A lower starting dose is recommended in patients with mild or moderate kidney or liver problems. Adcirca is not recommended for patients with severe kidney or liver problems. For more information about using Adcirca, see the package leaflet or contact your healthcare provider.

How does Adcirca work?

PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs. This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.The active substance in Adcirca, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs. When the enzyme is blocked, a substance called 'cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes therelaxation and widening of the blood vessels. In patients with PAH, this lowers the blood pressure in the lungs and improves symptoms.

What benefits of Adcirca have been shown in studies?

Adcirca was more effective than placebo at improving exercise capacity based on one main study involving 406 patients with PAH, most of whom had class II or class III disease. Before treatment, these patients could walk an average of 343 metres in six minutes. After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.An additional study in 35 children with PAH also showed that treatment with Adcirca led to an improvement in the distance the children could walk in six minutes with Adcirca, which was consistent with that observed in adults.

What is the risk associated with Adcirca?

The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn)including abdominal (belly) pain or discomfort, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).Adcirca must not be used in patients who have had an acute myocardial infarction (sudden heart attack) within the last three months, or who have severe hypotension (low blood pressure). Adcirca must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class'guanylate cyclase stimulators' such as riociguat (another medicine to treat pulmonary hypertension). It must not be used in patients who have ever had loss of vision because of a problem called nonarteritic anterior ischaemic optic neuropathy (NAION) that affects the blood flow to the nerve in the eye.For the full list of all side effects and restrictions with Adcirca, see the package leaflet.

Why has Adcirca been approved?

The European Medicines Agency decided that Adcirca's benefits are greater than its risks and it can be authorised for use in the EU. Studies show that Adcirca improved walking ability in adults and children, and the side effects are manageable.

What measures are being taken to ensure the safe and effective use of Adcirca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcirca have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Adcirca are continuously monitored. Suspected side effects reported with Adcirca are carefully evaluated and any necessary action taken to protect patients.Adcirca0F (tadalafil)


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Adempas


What is Adempas and what is it used for?

Adempas is a medicine that is used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs). It is used in the following types of PAH:• Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots). Adempas is used to treat adult patients with CTEPH who cannot have surgery, or in whom CTEPH remains or returns after surgery.• Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed) in adults and in children weighing more than 50 kg. In adults with PAH, Adempas can be used on its own or in combination with other medicines for PAH called 'endothelin receptor antagonists' whereas in children it is used with endothelin receptor antagonists.Adempas is used in patients with functional class II to III CTEPH or PAH. The 'class' reflects the seriousness of the disease: 'class II' involves a slight limitation of physical activity while 'class III' involves a marked limitation of physical activity.CTEPH and PAH are rare, and Adempas was designated an 'orphan medicine' (a medicine used in rare diseases) on 20 December 2007. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.Adempas contains the active substance riociguat.

How is Adempas used?

Adempas can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of CTEPH or PAH.Adempas is available as tablets. For patients unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft food such as apple sauce.The usual recommended starting dose is 1 mg three times a day (approximately 6 to 8 hours apart) for two weeks. The dose is then increased every two weeks based on the patients' systolic blood pressure (blood pressure when the heart is contracting) until the appropriate dose for the individual patient is established. Treatment with the established dose should continue unless patients experience signs and symptoms of low blood pressure, in which case the dose should be reduced.For more information about using Adempas, see the package leaflet or contact your healthcare provider.

How does Adempas work?

CTEPH and PAH are debilitating diseases where there is severe narrowing of the blood vessels of the lungs. This causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the blood flow to the lungs. As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.The active substance in Adempas, riociguat, stimulates an enzyme called 'soluble guanylate cyclase' in the blood vessels of the lungs, causing the blood vessels to relax and widen. This helps to lower the blood pressure in the lungs and improve symptoms of CTEPH and PAH.

What benefits of Adempas have been shown in studies?

Adempas has been shown to be effective at improving exercise capacity, measured as the distance patients with CTEPH or PAH could walk in 6 minutes:• Adempas was compared with placebo (a dummy treatment) in one main study in 262 adult patients with CTEPH who could not have surgery, or in whom CTEPH remained or returned after surgery. Before treatment, the patients could walk an average of 347 metres in 6 minutes. After 16 weeks of treatment with Adempas, patients could walk an average of 46 metres further in 6 minutes than patients taking placebo.• The medicine was also compared with placebo in another main study in 445 adult patients with PAH. Before treatment, the patients could walk an average of 363 metres in 6 minutes. After 12 weeks, patients treated with Adempas could walk an average of 36 metres further in 6 minutes than patients taking placebo.• A main study also showed that Adempas can improve walking distance and other signs of heart function in children. Based on evidence from this study, the medicine is expected to work as well in children as it does in adults.

What are the risks associated with Adempas?

For the full list of side effects and restrictions with Adempas, see the package leaflet.The most common side effects with Adempas (which may affect more than 1 in 10 people) include headache, dizziness, dyspepsia (heartburn), peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), diarrhoea and vomiting. Serious side effects include haemoptysis (coughing up blood) and pulmonary haemorrhage (bleeding in the lungs).Adempas must not be used in patients with severely reduced liver function, with low systolic blood pressure (blood pressure when the heart is contracting) or with pulmonary hypertension associated with idiopathic interstitial pneumonia (scarring of the lungs with unknown cause). It must also not be used during pregnancy, or together with certain other medicines used to treat heart conditions.

Why is Adempas approved?

The European Medicines Agency considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH. It also noted that no other medicines have been authorised for CTEPH. Regarding safety it considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan. The Agency therefore decided that Adempas's benefits are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Adempas?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adempas have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Adempas are continuously monitored. Side effects reported with Adempas are carefully evaluated and any necessary action taken to protect patients.


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Adenuric


What is Adenuric?

Adenuric is a medicine that contains the active substance febuxostat. It is available as tablets (80 and 120 mg).

What is Adenuric used for?

Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or 'urate' in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as 'gout'. Adenuric is used in patients who already have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi ('stones', larger deposits of urate crystals that can cause joint and bone damage).Adenuric is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are on chemotherapy and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).The medicine can only be obtained with a prescription.

How is Adenuric used?

For the treatment of long-term hyperuricaemia, the recommended dose of Adenuric is 80 mg once a day. This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks. Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric. Adenuric treatment should not be stopped if an attack of gout occurs.For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day. Adenuric should be started two days before chemotherapy and continued for at least 7 days.

How does Adenuric work?

The active substance in Adenuric, febuxostat, reduces the formation of uric acid. It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body. By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up. This can reduce the symptoms of gout. Keeping uric acid levels low for long enough can also shrink tophi. In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.

How has Adenuric been studied?

For the treatment of hyperuricaemia and gout, Adenuric has been studied in two main studies involving a total of 1,834 patients. The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia). The study lasted six months. The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.In both studies, allopurinol was used at a dose of 300 mg once a day, except in patients with kidney problems, who took 100 mg. The main measure of effectiveness was the number of patients whose final three blood uric acid levels were below 6 mg/dl. Blood uric acid levels were measured every month.For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, Adenuric has been studied in one main study involving 346 adult patients undergoing chemotherapy for blood cancer. Patients received either Adenuric or allopurinol for 7 to 9 days. The main measure of effectiveness was based on their blood uric acid levels.

What benefit has Adenuric shown during the studies?

Adenuric was more effective than allopurinol and placebo in treating hyperuricaemia by reducing blood uric acid levels. In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements. This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo. Similar results were seen in the second study after a year.In patients with blood cancer who were undergoing chemotherapy, Adenuric was as effective as allopurinol in controlling blood levels of uric acid: in 98.3 % of patients (170 out of 173) on Adenuric blood levels of uric acid normalised compared with 96 % (166 out of 173) of patients on allopurinol.

What is the risk associated with Adenuric?

The most commonly reported side effects with Adenuric are gout flare-ups, abnormal liver test results, diarrhoea, nausea (feeling sick), headache, rash and oedema (swelling). These side effects were mostly mild or moderate in severity. Rare serious hypersensitivity (allergic) reactions to Adenuric have occurred post-marketing.For the full list of all side effects and restrictions with Adenuric, see the package leaflet.

Why has Adenuric been approved?

The CHMP concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels including in patients undergoing chemotherapy , but that it could carry a greater risk of side effects affecting the heart and blood vessels. The Committee decided that Adenuric's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Adenuric?

A risk management plan has been developed to ensure that Adenuric is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adenuric, including the appropriate precautions to be followed by healthcare professionals and patients.


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Adjupanrix


What is Adjupanrix?

Adjupanrix is a vaccine that is given by injection. It contains parts of influenza (flu) viruses that have been inactivated (killed). The vaccine contains a flu strain called 'A/VietNam/1194/2004 NIBRG 14' (H5N1).This vaccine is the same as the Pandemrix H5N1 mock-up vaccine, which was previously authorised in the European Union (EU). The company that made the Pandemrix H5N1 mock-up vaccine has agreed that its scientific data can be used for this vaccine.

What is this vaccine used for?

Adjupanrix is a vaccine for use in adults to protect against 'pandemic' flu. It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU). A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. The vaccine would be given according to official recommendations.The vaccine can only be obtained with a prescription.

How is this vaccine used?

The vaccine is given by injection into the shoulder or thigh muscle. People who have not previously been vaccinated against the pandemic flu with a 'prepandemic' vaccine should receive two single0.5 ml doses of the vaccine at least three weeks apart. Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder) with a second double dose three weeks later. People who have previously been vaccinated with a prepandemic vaccine that contains a similar flu strain to the one causing the pandemic will only need one single dose.There are some data supporting the use of half-doses (0.25 ml) in children three to nine years of age.

How does this vaccine work?

Adjupanrix is a 'mock-up' vaccine. This is a special type of vaccine that can be developed to help with the management of a future pandemic.Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance. Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because very few people have been exposed to it, and to which very few people are immune. They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. This vaccine contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1. The virus has first been inactivated so that it does not cause any disease. During a pandemic, the virus strain in the vaccine will have to be replaced by the strain causing the pandemic before the vaccine can be used.When a person is given the vaccine, the immune system recognises the virus as 'foreign' and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This will help to protect against the disease caused by the virus.Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with a solvent. The resulting 'emulsion' will then be injected. The solvent contains an 'adjuvant' (a compound containing oil) to enhance the immune response.

How has this vaccine been studied?

The main study of the vaccine included 400 healthy adults aged between 18 and 60 years and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies ('immunogenicity'). The participants received two injections of the vaccine containing one of four different doses of haemagglutinin. The injections were given 21 days apart. The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42). A further study looked at the immunogenicity of single or double doses in 437 people aged over 60 years, and two studies looked at the effect of giving a single injection of the vaccine to adults who had previously been vaccinated with a prepandemic vaccine containing a related virus strain.A study in 405 children three to nine years of age looked at the immunogenicity triggered by a vaccine containing half the amount of haemagglutinins compared with the vaccine containing the full amount.

What benefit has this vaccine shown during the studies?

According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.The main study showed that the 3.75 microgram dose of the adjuvanted vaccine produced an antibody response that met these criteria. At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.In elderly people, single doses also met the CHMP's criteria, except for in the small number of patients aged over 80 years who did not have any protection against the virus at the start of the study. These patients needed double doses of the vaccine for protection.The final two studies in adults showed that a single dose of the vaccine was sufficient to bring about protective levels of antibodies in people who had previously been vaccinated with a prepandemic vaccine containing a related flu strain.In children aged three to nine years, the half-dose vaccine was shown bring about levels of antibodies that were comparable with the full-dose vaccine.

What is the risk associated with this vaccine?

The most common side effects with the vaccine (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection(hardening, swelling, pain and redness), fever and fatigue (tiredness). For the full list of all side effects reported with this vaccine, see the package leaflet.The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at very low levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate. If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.

Why has Adjupanrix been approved?

The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.The vaccine has been authorised under 'exceptional circumstances'. This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited?

When the company that makes the vaccine includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.


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Adrovance


What is Adrovance?

Adrovance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3). It is available as white tablets (capsule-shaped: 70 mg alendronic acid and 2,800 international units [IU] colecalciferol; rectangular: 70 mg alendronic acid and 5,600 IU colecalciferol).

What is Adrovance used for?

Adrovance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels. Adrovance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements. Adrovance reduces the risk of broken bones in the spine and the hip.The medicine can only be obtained with a prescription.

How is Adrovance used?

The recommended dose of Adrovance is one tablet once a week. It is intended for long-term use.The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins). To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet. The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.

How does Adrovance work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.Adrovance contains two active substances: alendronic acid and colecalciferol (vitamin D3).Alendronic acid is a bisphosphonate that has been used in osteoporosis since the mid-1990s. It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss. Vitamin D3 is a nutrient that is found in some foods, but also made in the skin through exposure to natural sunlight. Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation. Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Adrovance.

How has Adrovance been studied?

Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Adrovance's ability to increase vitamin D levels. Patients received either Adrovance 70 mg/2,800 IU or alendronic acid only once a week. The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks. This study was extended in 652 patients for a further 24 weeks to compare the effects on continuing with Adrovance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Adrovance 70 mg/5,600 IU).

What benefit has Adrovance shown during the studies?

The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Adrovance was the same as the dose needed to prevent bone loss.The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels. After 15 weeks, fewer patients had low vitamin D levels when they took Adrovance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%). In the extension study, similar numbers of patients taking Adrovance 70 mg/2,800 IU and Adrovance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Adrovance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.

What is the risk associated with Adrovance?

The most common side effects with Adrovance are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletalpain (pain in the muscles, bones and joints). For the full list of all side effects reported with Adrovance, see the package leaflet.Adrovance should not be used in people who may be hypersensitive (allergic) to alendronic acid, vitamin D3 or any of the other ingredients. It must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low calcium levels), or who cannot stand or sit upright for at least 30 minutes.

Why has Adrovance been approved?

The CHMP decided that Adrovance's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Adtralza


What is Adtralza and what is it used for?

Adtralza is a medicine for treating adults and children above 12 years of age with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry). It is used in patients for whom treatment applied directly to the skin cannot be used or is not sufficient.Adtralza contains the active substance tralokinumab.

How is Adtralza used?

Adtralza is available as a solution for injection under the skin. The first dose is four injections of 150 mg, each into a different location. This is followed by two injections of 150 mg every two weeks. The medicine can only be obtained with a prescription.For more information about using Adtralza, see the package leaflet or contact your doctor or pharmacist.

How does Adtralza work?

Patients with atopic dermatitis produce high levels of a protein called interleukin 13 (IL-13), which can cause inflammation of the skin leading to the symptoms of this disease such as redness, swelling and itching. The active substance in Adtralza, tralokinumab, is a type of protein (monoclonal antibody) designed to neutralise IL-13. By neutralising IL-13, tralokinumab prevents it from working and thereby reduces the inflammation and patient's symptoms.

What benefits of Adtralza have been shown in studies?

Adtralza was more effective than a placebo (dummy treatment) at reducing the extent and severity of atopic dermatitis after 16 weeks of treatment in three main studies in adult patients with moderate to severe disease that had not responded well enough to treatment applied to the skin. The main measures of effectiveness were having clear or almost clear skin, and a reduction in symptom score of at least 75%.In the first study, which involved 802 patients, around 16% of patients who received Adtralza had clear skin or almost clear skin compared with 7% of those who received placebo. Symptoms weresatisfactorily reduced in 25% of patients who received Adtralza, compared with about 13% of those who received placebo.In the second study, involving 794 patients, treatment with Adtralza led to clear or almost clear skin in about 22% of patients, compared with around 11% of patients who used a placebo. Symptoms were satisfactorily reduced in 33% of patients receiving Adtralza versus about 11% of those receiving placebo.In the third study, 380 patients were given Adtralza or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin). Adtralza treatment led to clear or almost clear skin in around 39% of patients versus 26% of those receiving placebo. Symptoms were satisfactorily reduced in 56% of the patients who received Adtralza, compared with about 36% of patients on placebo.In an additional study involving 301 children aged between 12 and 17 years with atopic dermatitis, treatment with Adtralza 300 mg every two weeks for 16 weeks led to clear or almost clear skin in around 18% of patients, while treatment with 150 mg every other week for 16 weeks led to clear or almost clear skin in around 21% of patients. This compared with around 4% of patients who used a placebo.

What are the risks associated with Adtralza?

The most common side effects with Adtralza in adults are upper respiratory tract infections (colds and other infections of the nose and throat) which may affect more than 1 in 10 people. Other common side effects include reactions at the injection site and redness and discomfort in the eye (which may affect up to 1 in 10 people). In children, studies showed that the safety profile is similar to that in adults.For the full list of side effects and restrictions of Adtralza, see the package leaflet.

Why is Adtralza authorised in the EU?

Four main studies have shown that Adtralza is effective at clearing the skin and reducing symptoms of atopic dermatitis. The side effects are considered manageable. The European Medicines Agency decided that Adtralza's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Adtralza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adtralza have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Adtralza are continuously monitored. Side effects reported with Adtralza are carefully evaluated and any necessary action taken to protect patients.


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Advagraf


What is Advagraf?

Advagraf is a medicine containing the active substance tacrolimus. It is available as prolongedreleased capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg:greyish-red and orange). 'Prolonged-release' means that tacrolimus is released slowly from the capsule over a few hours.

What is Advagraf used for?

Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ). Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective. The medicine can only be obtained with a prescription.

How is Advagraf used?

Treatment with Advagraf should only be prescribed by doctors who have experience in the management of transplant patients.Advagraf is for long-term use. Doses are calculated based on the patient's weight. Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges. In the prevention of rejection, the dose of Advagraf to use depends on the type of transplant the patient has received. In kidney transplant, the starting dose is 0.20 to 0.30 mg per kilogram body weight. In liver transplant, the starting dose is 0.10 to 0.20 mg/kg.When treating rejection, these same doses may be used in kidney and liver transplants. Starting doses are 0.10 to 0.30 mg/kg in other types of transplant (heart, lung, pancreas or intestine).Advagraf is given once a day, in the morning, at least one hour before or two to three hours after food.

How does Advagraf work?

Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent. This means that it reduces the activity of the immune system (the body's natural defences). Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).Tacrolimus has been used since the mid-1990's. In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country). Advagraf is very similar toPrograf/Prograft, but the way the medicine is made has been changed so that the active substance isreleased more slowly from the capsule than it is in Prograf/Prograft. This allows Advagraf to be given once a day, whereas Prograf/Prograft is given twice a day. This can help the patients stick to their treatment.

How has Advagraf been studied?

Because tacrolimus and Prograf/Prograft have already been used in the EU, the company presented the results of studies that had been carried out with Prograf/Prograft previously, as well as data from the published literature. It also presented the results of a clinical study in 668 kidney transplant patients comparing the use of Advagraf with that of Prograf/Prograft or ciclosporin (another immunosuppressive medicine used in the prevention of rejection). Patients also received mycophenolate mofetil (another medicine used in the prevention of rejection). The main measure of effectiveness was the number of patients in whom the transplant failed (as measured by looking at, for example, the need for a repeat transplant or a return to dialysis) after one year's treatment. Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf is absorbed by the body in comparison to Prograf/Prograft.

What benefit has Advagraf shown during the studies?

Advagraf was as effective as both comparator medicines. After one year, 14% of the patients receivingAdvagraf had experienced organ failure. The percentages were 15% in the patients treated with Prograf/Prograft, and 17% in those treated with ciclosporin. The shorter studies in kidney and liver transplant patients showed that Advagraf and Prograf/Prograft have comparable absorption in the body.

What is the risk associated with Advagraf?

The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping). For the full list of all side effects reported with Advagraf, see the Package Leaflet.Advagraf should not be used in people who may be hypersensitive (allergic) to tacrolimus, to macrolide antibiotics (such as erythromycin) or to any of the other ingredients.Patients and doctors must be careful when other medicines (including some herbal remedies) are taken at the same time as Advagraf, as there may be a need to adjust the dose of Advagraf or the dose of the medicine it is taken with. See the Package Leaflet for details.

Why has Advagraf been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf's benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. The Committee recommended that Advagraf be given marketing authorisation.


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Advate


What is Advate and what is it used for?

Advate is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance octocog alfa (human coagulation factor VIII).

How is Advate used?

Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and duration of treatment depend on whether Advate is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight. Advate is intended for either short-term or long-term use.Patients or their carers may be able to administer Advate themselves at home once they have been trained appropriately. For full details, see the package leaflet.

How does Advate work?

The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot. Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs. Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.Octocog alfa is made by a method known as 'recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.

What benefits of Advate have been shown in studies?

Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine. Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from 'none' to 'excellent' in 107 patients, all of whom received Advate. The effectiveness of Advate was rated as 'excellent' or 'good' in 86% of 510 new bleeding episodes. In addition, 81% of these bleeding episodes required only a single treatment with Advate.Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years. The additional studies confirmed Advate's effectiveness, including in children under 6 years of age.Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control. Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective. The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.

What are the risks associated with Advate?

Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).Hypersensitivity (allergic) reactions have been reported and may in some cases become severe.There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.For the full list of all side effects reported with Advate, see the package leaflet. Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.

Why is Advate approved?

The Agency decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation. The Agency concluded that Advate has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.

What measures are being taken to ensure the safe and effective use of Advate?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advate have been included in the summary of product characteristics and the package leaflet.


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Adynovi


What is Adynovi and what is it used for?

Adynovi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII. It can be used in adults and children from 12 years of age.Adynovi contains the active substance rurioctocog alfa pegol.

How is Adynovi used?

Adynovi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.Adynovi is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight. Patients or their carers may be able to inject Adynovi themselves at home once they have been trained appropriately.For further details, see the package leaflet.

How does Adynovi work?

Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Adynovi, rurioctocog alfa pegol, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.

What benefits of Adynovi have been shown in studies?

Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.In a study involving 138 adults and adolescents aged 12 years or above, 120 patients given Adynovi as a twice-weekly preventive treatment had, on average, around 4 bleeding episodes a year, and 17 patients given Adynovi for treating bleedings 'on demand' had around 43 bleeding episodes a year. In addition, when bleeding did occur, Adynovi was rated excellent or good at treating around 96% of bleeding episodes. Around 96% of bleeding episodes resolved with one or two injections of Adynovi.In the second study in 66 children aged below 12 years, all patients were given Adynovi as a twiceweekly preventive treatment for around 6 months. During this period, around 38% of patients (25 out of 66) had no bleeding episodes, and none of the patients developed antibodies against Adynovi, which can cause the medicine to stop working. When bleeding occurred, Adynovi was rated excellent or good at treating around 90% of episodes. Around 83% of bleeding episodes resolved with one injection.

What are the risks associated with Adynovi?

Hypersensitivity (allergic) reactions are uncommon with Adynovi (affecting up to 1 in 100 people) and may include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.Following treatment with factor VIII products, including Adynovi, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.For the full list of all side effects see the package leaflet.Adynovi must not be used in patients who are hypersensitive (allergic) to rurioctocog alfa pegol or the related substance octocog alfa or to any of the other ingredients of the medicine, nor in those with known allergy to mouse or hamster proteins.

Why is Adynovi approved?

The European Medicines Agency decided that Adynovi's benefits are greater than its risks and recommended that it be approved for use in the EU. Studies show that Adynovi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products. However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment. Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.

What measures are being taken to ensure the safe and effective use of Adynovi?

The company that markets Adynovi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adynovi have also been included in the summary of product characteristics and the package leaflet.


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Aerinaze


What is Aerinaze?

Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg). It is available as blue and white modified-release tablets. 'Modified-release' means that the tablets have been made to allow one of the active substances to be released immediately and the other one released over a few hours.

What is Aerinaze used for?

Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).The medicine can only be obtained with a prescription.

How is Aerinaze used?

In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water. Treatment should continue for as short a time as possible and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared. Treatment for more than 10 days is not advisable, as the medicine's effects on nasal congestion may wear off. Once the nose has cleared, patients can use desloratadine alone.

How does Aerinaze work?

Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which is a nasal decongestant. Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy. Pseudoephedrine works by stimulating nerve endings to release the chemical noradrenaline, which causes the blood vessels to constrict (narrow). This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose. In Aerinaze, the two active substances are used together, since an antihistamine alone may not provide adequate relief for patients with nasal congestion.Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine. Desloratadine is released from its layer immediately after it is taken, while pseudoephedrine is released slowly over 12 hours. This means that patients only need to take the tablet twice a day.Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is widely used in medicines that have been available over-the-counter for many years.

How has Aerinaze been studied?

The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients. In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone. The main measures of effectiveness were the change in the severity of hayfever symptoms reported by the patients between before treatment started, and over the entire 15 days of treatment. The patients recorded their symptoms in a diary every 12 hours during the study, scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour period.

What benefit has Aerinaze shown during the studies?

Aerinaze was more effective in reducing symptoms than either of the two active substances taken alone. When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone. When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone. Similar results were seen in the second study.

What is the risk associated with Aerinaze?

The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness. For the full list of all side effects reported with Aerinaze, see the Package Leaflet.Aerinaze must not be used in people who are hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies). It should not be used in people who are taking a monoamine oxidase inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these medicines within the last two weeks. Aerinaze should also not be taken by people who have narrow-angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).

Why has Aerinaze been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion and recommended that Aerinaze be given marketing authorisation.


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Aerius


What is Aerius?

Aerius is a medicine containing the active substance desloratadine. It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a0.5 mg/ml oral solution.

What is Aerius used for?

Aerius is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).The medicine can only be obtained with a prescription.

How is Aerius used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day. The dose in children depends on their age. For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution. For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet. Adults and adolescents can use any form of the medicine.

How does Aerius work?

The active substance in Aerius, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Aerius been studied?

Aerius has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma). The effectiveness of Aerius was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.Aerius has also been studied in 416 patients with urticaria. The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.In all studies, the effectiveness of Aerius was compared with that of placebo (a dummy treatment).Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.

What benefit has Aerius shown during the studies?

In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with5 mg Aerius led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo. In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Aerius was 58 and 67%, compared with 40 and 33% in placebo-treated patients.

What is the risk associated with Aerius?

In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%). The side effects seen in children are similar. In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%). For the full list of all side effects reported with Aerius, see the package leaflet.Aerius must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.

Why has Aerius been approved?

The CHMP decided that Aerius's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.


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Afinitor


What is Afinitor and what is it used for?

Afinitor is a cancer medicine used to treat the following cancers:• breast cancer that is advanced (has started to spread) in women who have been through their menopause. Afinitor is used in breast cancer that is 'hormone receptor-positive' (when the cancer cells have oestrogen receptors on their surface) and 'HER2/neu negative' (when the cancer cells do not contain high levels of the HER2/neu [human epidermal growth factor receptor-2] protein). Afinitor is used together with a medicine called exemestane after other treatments called 'nonsteroidal aromatase inhibitors' have not worked;• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) when the cancer cells are well- or moderately differentiated (which means that they can be distinguished from normal pancreas cells). It is used when the cancer is metastatic (has spread to other parts of the body) or when it cannot be surgically removed;• neuroendocrine tumours originating in the lungs or gut, when the cancer cells are welldifferentiated and the cancer is metastatic or cannot be removed by surgery.• advanced renal cell carcinoma (a kidney cancer), when the cancer has worsened despite treatment with a 'VEGF-targeted' medicine (a type of medicine that blocks the effects of vascular endothelial growth factor proteins).Afinitor contains the active substance everolimus.

How is Afinitor used?

Afinitor can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer treatments.Afinitor is available as tablets (2.5, 5 and 10 mg) and the recommended dose is 10 mg once a day. Treatment should continue for as long as it works or until side effects become unacceptable. The doctor may reduce the dose or stop treatment for a short period if the patient has severe or intolerable side effects. Doses need to be reduced for patients with liver problems.The tablets should be taken at the same time every day and consistently with or without food.For more information about using Afinitor, see the package leaflet or contact your doctor or pharmacist.

How does Afinitor work?

The active substance in Afinitor, everolimus, blocks an enzyme called 'mammalian target of rapamycin' (mTOR). In the body, everolimus first attaches to a protein called FKBP-12 that is found inside cells to make a 'complex'. This complex then blocks mTOR. Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply. This slows down the growth and spread of the cancer.

What benefits of Afinitor have been shown in studies?

Breast cancerAfinitor in combination with exemestane has been studied in 724 patients with hormone receptorpositive and HER2/neu-negative advanced breast cancer which had got worse after treatment with letrozole and anastrazole (non-steroidal aromatase inhibitors). Patients who took Afinitor lived for an average of 7.8 months without their disease getting worse, compared with 3.2 months for the patients who took placebo (a dummy treatment).Pancreatic neuroendocrine tumoursA study in 410 patients with advanced well- or moderately differentiated neuroendocrine tumours of pancreatic origin compared Afinitor with placebo. Patients who took Afinitor lived for an average of 11.0 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.Neuroendocrine tumours originating in the lung or gutAfinitor was studied in 302 patients with advanced neuroendocrine tumours of lung or gut origin. Patients who received Afinitor and best supportive treatments lived for an average of 11 months without the disease getting worse compared with around 4 months for patients who received placebo and best supportive treatments to relieve disease symptoms.Renal cell carcinomaAfinitor was studied in 416 patients with advanced renal cell carcinoma that had got worse despite treatment with VEGF-targeted medicines (sunitinib, sorafenib or both). Patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.

What are the risks associated with Afinitor?

The most common side effects with Afinitor (which may affect more than 1 in 10 people) are rash, itching, nausea, decreased appetite, dysgeusia (taste disturbances), headache, weight loss, peripheral oedema (swelling, especially of the ankles and feet), cough, anaemia (low red blood cell counts), tiredness, diarrhoea, weakness, infections, stomatitis (inflammation of the lining of the mouth), hyperglycaemia (high blood glucose levels), hypercholesterolaemia (high blood cholesterol levels), pneumonitis (inflammation of the lungs) and nosebleeds. For the full list of side effects of Afinitor, see the package leaflet.Afinitor must not be used in people who are hypersensitive (allergic) to other rapamycin derivatives (substances with a similar structure to everolimus) or to any of the other ingredients. For the full list of restrictions, see the package leaflet.

Why is Afinitor authorised in the EU?

The European Medicines Agency decided that Afinitor's benefits are greater than its risks and it can be authorised for use in the EU. Afinitor slowed down disease progression in patients with advanced neuroendocrine tumours of pancreatic origin, advanced renal cell carcinoma and hormone-receptorpositive advanced breast cancer. The Agency also concluded that the 7-month delay in disease progression for patients with neuroendocrine tumours originating in the lungs or gut was valuable, despite the known side effects of Afinitor.

What measures are being taken to ensure the safe and effective use of Afinitor?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Afinitor have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Afinitor are continuously monitored. Side effects reported with Afinitor are carefully evaluated and any necessary action taken to protect patients.


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Aflunov


What is Aflunov and what is it used for?

Aflunov is a vaccine used in adults to protect against flu caused by the H5N1 ('bird flu') strain of the influenza A virus. Aflunov contains parts of influenza (flu) viruses that have been inactivated. Aflunov contains a flu strain called A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).

How is Aflunov used?

The vaccine is given by injection into the shoulder muscle in two single doses, at least three weeks apart. In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Aflunov (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.Aflunov can only be obtained with a prescription and should be used according to official recommendations

How does Aflunov work?

Aflunov is a type of vaccine to be given before or during a flu pandemic to protect against a new strain of flu. A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people do not have immunity (protection) against it. Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus, an infection that can spread from birds to humans (a 'zoonotic' infection).Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a specific disease. This vaccine contains some parts of the H5N1 virus. The virus has first been inactivated so that it does not cause any disease. When a person is given the vaccine, the immune system recognises the virus parts in the vaccine as 'foreign' and makes antibodies against them. When the person comes into contact with the virus, these antibodies, together with other components of the immune system, will be able to kill the virus and help protect against the disease.The vaccine contains an 'adjuvant' (a compound containing oil) to enhance the immune response.

What benefits of Aflunov have been shown in studies?

Aflunov has been shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.At the time of the initial marketing authorisation, two main studies using a strain calledA/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) provided data on vaccination with Aflunov in healthy adults aged below and above 60 years. In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Aflunov three weeks apart, or placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart. In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.In the second study involving 240 people, subjects were given Aflunov using different vaccination schedules. The studies looked at the ability of the vaccine to trigger the production of antibodies ('immunogenicity') against the flu virus. This study established that Aflunov should be given as two doses at least three weeks apart.A third study, using a vaccine with strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23), was carried out in 343 adults aged below and above 60 years. The study showed that 21 days after the second injection, around 70% of adults below 60 years and around 64% of adults above 60 years produced an acceptable antibody response.

What are the risks associated with Aflunov?

The most common side effects with Aflunov (which may affect more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness). For the full list of side effects of Aflunov, see the package leaflet.Aflunov should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low) levels (egg or chicken protein, ovalbumin [a protein in egg white], kanamycin or neomycin sulphate [antibiotics], barium sulphate, formaldehyde and cetyltrimethylammonium bromide). However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.

Why is Aflunov authorised in the EU?

It was noted that it is likely that a H5N1 strain of influenza will cause a pandemic in the future and Aflunov was shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1. The European Medicines Agency therefore decided that Aflunov's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aflunov?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aflunov have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aflunov are continuously monitored. Side effects reported with Aflunov are carefully evaluated and any necessary action taken to protect patients.


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Afstyla


What is Afstyla and what is it used for?

Afstyla is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII). It contains the active substance lonoctocog alfa.

How is Afstyla used?

Afstyla is available as a powder and solvent used to make a solution for injection. The injection is given into a vein over several minutes. The dose and frequency of the injections depend on whether Afstyla is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.Afstyla can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia. For further information, see the package leaflet.

How does Afstyla work?

Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.The active substance in Afstyla, lonoctocog alfa, is a shorter version of human factor VIII that works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.

What benefits of Afstyla have been shown in studies?

Afstyla has been shown to be effective at preventing and treating bleeding episodes in two main studies in patients with severe haemophilia A who were previously treated with other factor VIII products.The first study involved 173 patients aged 12 years and above. A total of 848 bleeding episodes were recorded during the study, 94% of which resolved with one or two injections of Afstyla. Afstyla was rated as 'excellent' or 'good' at treating 92% of the bleeding episodes. In the 16 surgical procedures that occurred during the study, Afstyla was rated as 'excellent' or 'good' in preventing bleeding episodes when used two to three times a week. Among those patients who received Afstyla to prevent bleeding, an average of 1.14 bleeding episodes per year was recorded for each patient which was lower than the 19.64 episodes per year in patients not receiving Afstyla for prevention.The second study involved 83 patients below 12 years of age. Afstyla was rated as 'excellent' or 'good' at treating 96% of the 347 bleeding episodes recorded during the study; 96% of bleeding episodes resolved with one or two injections of Afstyla. Among those patients who received Afstyla to prevent bleeding, the average number of bleeding episodes per year was 2.30 for patients receiving Afstyla three times a week, and 4.37 for those receiving Afstyla twice a week.

What are the risks associated with Afstyla?

Hypersensitivity (allergic) reactions are common with Afstyla, affecting up to 1 in 10 people. They may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing. In some cases these reactions can become severe.There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.Afstyla must not be used in patients with known allergy to hamster proteins.For the full list of all side effects and restrictions, see the package leaflet.

Why is Afstyla approved?

Afstyla has been shown to be effective in both preventing and treating bleeding episodes. Regarding safety, the reported side effects are in line with those expected for a factor VIII product, although hypersensitivity reactions occurred more frequently with Afstyla. Further safety data should be provided by ongoing studies.The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Afstyla's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Afstyla?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Afstyla have been included in the summary of product characteristics and the package leaflet.


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Aimovig


What is Aimovig and what is it used for?

Aimovig is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.Aimovig contains the active substance erenumab.

How is Aimovig used?

Aimovig is injected under the skin using a pre-filled syringe or pen. Patients can inject the medicine themselves after being trained.The recommended dose is 70 mg every 4 weeks as a single injection. Some patients may benefit from a dose of 140 mg every 4 weeks, given as either a single injection of 140 mg or two injections of 70 mg.Aimovig can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of migraine. For more information about using Aimovig, see the package leaflet or contact your doctor or pharmacist.

How does Aimovig work?

A chemical messenger called CGRP has been shown to be involved in the development of migraine. The active substance in Aimovig, erenumab, is a monoclonal antibody (a type of protein) designed to attach to a receptor (target) for CGRP on body's cells. By attaching to this receptor, the medicine stops CGRP from attaching to it and causing migraine.

What benefits of Aimovig have been shown in studies?

Aimovig is effective at reducing the number of days patients suffer migraines. In a study of 667 patients who had migraines 18 days a month on average, those treated with Aimovig had 7 fewer days with migraines per month, compared with 4 fewer days for patients on placebo.In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo.

What are the risks associated with Aimovig?

The most common side effects with Aimovig (which may affect up to 1 in 10 people) are reactions at the site of injection, constipation, muscle spasms and itching.For the full list of side effects and restrictions of Aimovig, see the package leaflet.

Why is Aimovig authorised in the EU?

Aimovig was shown to be effective at reducing the number of days patients have migraines. Only patients with migraines at least 4 days a month were included in the studies as patients with less frequent migraines are not usually eligible for preventative treatment.Most of the side effects are mild or moderate in severity. The European Medicines Agency therefore decided that Aimovig's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aimovig?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aimovig have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aimovig are continuously monitored. Side effects reported with Aimovig are carefully evaluated and any necessary action taken to protect patients.


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Ajovy


What is Ajovy and what is it used for?

Ajovy is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.The active substance contained in Ajovy is fremanezumab.

How is Ajovy used?

Ajovy is injected under the skin using a pre-filled syringe. Patients can inject the medicine themselves after being trained.The recommended dose is either 225 mg every month or 675 mg every three months. For the 675 mg dose, three injections of 225 mg have to be injected one after another, each in a different place.Ajovy can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of migraine.For more information about using Ajovy, see the package leaflet or contact your doctor or pharmacist.

How does Ajovy work?

A chemical messenger called CGRP contributes to the development of migraine. Ajovy is a monoclonal antibody (a type of protein) designed to attach to CGRP and prevent it from binding to its target on the body's cells thereby helping to prevent migraines from occurring.

What benefits of Ajovy have been shown in studies?

Ajovy was shown to reduce the number of days patients have moderate to severe headaches and migraines in 2 main studies.In a study of 1,130 patients who had moderate to severe headaches 13 days a month on average, those treated with Ajovy had between 4 and 5 fewer days with moderate to severe headaches per month compared with 2 to 3 fewer days for patients on placebo (a dummy treatment), during the 12 week-study.In a study with 875 patients who had migraines 9 days a month on average, those treated with Ajovy had between 3 and 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo, during the 12 week-study.

What are the risks associated with Ajovy?

The most common side effects with Ajovy (which may affect more than 1 in 10 people) are reactions at the site of injection: pain, hardening (induration) and reddening of the skin (erythema).For the full list of side effects and restrictions of Ajovy, see the package leaflet.

Why is Ajovy authorised in the EU?

Ajovy can reduce the number of days patients have moderate to severe headaches and migraines. As most of the side effects are manageable and mild or moderate in severity, the European Medicines Agency decided that Ajovy's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Ajovy?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ajovy have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Ajovy are continuously monitored. Side effects reported with Ajovy are carefully evaluated and any necessary action taken to protect patients.


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Akeega


What is Akeega and what is it used for?

Akeega is a cancer medicine for treating adult patients with castration-resistant prostate cancer that has spread to other parts of the body.It is used when medical or surgical treatment to lower testosterone levels (castration) has not worked.Akeega is for patients who have genetic mutations known as BRCA 1/2 mutations and who cannot have chemotherapy. It is used in combination with prednisolone or another medicine prednisone, which is converted into prednisolone.Akeega contains two active substances: niraparib and abiraterone acetate.

How is Akeega used?

Akeega is available as tablets to be taken by mouth on an empty stomach. The patient should take the medicine once a day for as long as they benefit from it or do not have unacceptable side effects.The medicine can only be obtained with a prescription. For more information about using Akeega, see the package leaflet or contact your doctor or pharmacist.

How does Akeega work?

Akeega contains two active substances: niraparib and abiraterone acetate. Niraparib blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells. The blocking of the PARP enzymes prevents cancer cells from repairing damaged DNA, and, as a result, the cancer cells die.The other active substance, abiraterone acetate, stops the body producing testosterone by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, abiraterone acetate helps slow the growth of the prostate cancer.

What benefits of Akeega have been shown in studies?

A main study involving 225 patients with castration-resistant prostate cancer and BRCA 1/2 mutations showed that Akeega was effective at slowing the worsening of the disease.In this study, the time it took for scans to show the disease getting worse was around 17 months in patients who received Akeega, compared to 11 months in those treated with abiraterone acetate plus placebo (a dummy treatment). Patients in both groups also received prednisone.

What are the risks associated with Akeega?

For the full list of side effects and restrictions with Akeega, see the package leaflet.The most common side effects with Akeega (which may affect more than 1 in 10 people) include anaemia (low levels of red blood cells), high blood pressure, constipation, tiredness, nausea, thrombocytopenia (low levels of blood platelets), difficulty breathing, back pain, reduced appetite, neutropenia (low levels of neutrophils, a type of white blood cell), joint pain, vomiting, low levels of potassium, dizziness, difficulty sleeping, high blood glucose levels and urinary tract infection.The most serious side effects include anaemia, high blood pressure, thrombocytopenia, neutropenia and increase levels of the liver enzyme alkaline phosphatase.Akeega must not be used in patients with severe liver problems and should not be administered in combination with Radium-223, a type of radiotherapy.Akeega is not for use in women. As it may cause harm to the unborn baby, patients engaged in sexual activity with a woman who is pregnant or can become pregnant should use contraception.

Why is Akeega authorised in the EU?

The main study showed that Akeega was effective at slowing the worsening of castration-resistant prostate cancer that has spread to other parts of the body in patients with BRCA 1/2 mutations who cannot receive chemotherapy.Most of side effects of Akeega are those seen when the individual active substances are used alone.Although some side effects were serious, they were generally manageable. The European Medicines Agency therefore decided that the benefits of Akeega are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Akeega?

The company that markets Akeega will provide further data on how well treatment prolongs patients' lives.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Akeega have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Akeega are continuously monitored. Suspected side effects reported with Akeega are carefully evaluated and any necessary action taken to protect patients.


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Akynzeo


What is Akynzeo and what is it used for?

Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adults with cancer who are receiving chemotherapy (medicines to treat cancer).Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy containing the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.Akynzeo is available as capsules and as a powder to be made up into a solution for injection. It contains the active substances netupitant and palonosetron (capsules) or fosnetupitant and palonosetron (powder).

How is Akynzeo used?

The recommended dose is one capsule taken by mouth one hour before starting chemotherapy or one injection given into a vein over 30 minutes before each chemotherapy cycle.The medicine can only be obtained with a prescription. For more information about using Akynzeo, see the package leaflet or contact your doctor or pharmacist.

How does Akynzeo work?

The active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy. Palonosetron blocks 5HT3 receptors in the gut, which are responsible for the immediate phase of nausea (that occurs within the first 24 hours). Netupitant works by blocking neurokinin-1 (NK1)-receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours). Fosnetupitant is a 'prodrug' of netupitant, meaning that it is converted into the active substance netupitant in the body.By having palonsetron and netupitant or fosnetupitant together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.Palonosetron, has been authorised on its own in the EU since 2005.

What benefits of Akynzeo have been shown in studies?

In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136).A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy. Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron. The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group. This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.

What are the risks associated with Akynzeo?

The most common side effects with Akynzeo (which may affect up to 1 in 10 people) are headache, constipation and fatigue. For the full list of side effects and restrictions, see the package leaflet.

Why is Akynzeo authorised in the EU?

The European Medicines Agency noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile. The Agency therefore concluded that the medicine's benefits are greater than its risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Akynzeo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Akynzeo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Akynzeo are continuously monitored. Side effects reported with Akynzeo are carefully evaluated and any necessary action taken to protect patients.


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Aldara


What is Aldara?

Aldara is a cream containing the active substance imiquimod. It is available as 250 mg sachets, each containing 12.5 mg imiquimod (5%).

What is Aldara used for?

Aldara is used in adults to treat the following skin diseases:• warts on the genitals and around the anus;• small basal cell carcinomas (slow-growing types of skin cancer);• actinic keratoses of the face and scalp (precancerous, abnormal skin growths that develop after too much exposure to sunlight), in patients whose immune system is working normally. It is used when other treatments such as cryotherapy (freezing) cannot be used. The medicine can only be obtained with a prescription.

How is Aldara used?

The number of times Aldara is applied and the duration of treatment depend on the condition being treated:• For genital warts, Aldara is applied three times a week for up to 16 weeks.• For small basal cell carcinomas, the cream is applied five times a week for six weeks.• For actinic keratoses, it is applied three times a week, for one or two four-week courses, with four weeks between courses.The cream is applied in a thin layer to the affected areas of skin before sleeping, so that it remains on the skin for a suitable length of time (about eight hours) before being washed off. For further information, see the Package Leaflet.

How does Aldara work?

The active substance in Aldara cream, imiquimod, is an immune response modifier. This means that it uses the immune system, the body's natural defences, to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon. These substances help to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.

How has Aldara been studied?

In all studies, Aldara was compared with placebo (the same cream but without the active substance).• Aldara has been studied in 923 patients with genital warts in four main studies lasting 16 weeks. The main measure of effectiveness was the number of patients with total clearance of treated warts.• Aldara has also been studied in 724 patients with small basal cell carcinomas in two studies where patients were treated for six weeks, and used Aldara or placebo either five times a week or every day. The main measure of effectiveness was the number of patients with total clearance of the tumours after 12 weeks.• Aldara has also been studied in patients with actinic keratoses in two studies involving a total of 505 patients. The main measure of effectiveness was the number of patients whose keratoses had cleared after one or two four-week courses of treatment.

What benefit has Aldara shown during the studies?

In all studies, Aldara was more effective than placebo.• In the treatment of genital warts, the total clearance rate across the four main studies was 15 to 52% in the Aldara-treated patients, compared with 3 to 18% in the placebo-treated patients.• When the results of the two studies in basal cell carcinoma were looked at together, total clearance was seen in 66 to 80% of Aldara-treated patients compared with 0 to 3% in the placebo group. There were no differences between the two dose frequencies.• In actinic keratoses, complete clearance after one or two courses of treatment was seen in 54 and 55% of Aldara-treated patients in the two studies, compared with 15 and 2% in the placebo-treated patients.

What is the risk associated with Aldara?

The most common side effect with Aldara (seen in more that 1 patient in 10) is a reaction at the site of application of the cream (pain or itching). For the full list of all side effects reported with Aldara, see the Package Leaflet.Aldara should not be used in people who may be hypersensitive (allergic) to imiquimod or any of the other ingredients.

Why has Aldara been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara's benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate. The Committee recommended that Aldara be given marketing authorisation.


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Aldurazyme


What is Aldurazyme?

Aldurazyme is a solution for infusion (drip) into a vein that contains the active substance laronidase.

What is Aldurazyme used for?

Aldurazyme is used in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; a L iduronidase deficiency) to treat the non-neurological symptoms of the disease (symptoms that are not connected with the brain or nerves). MPS I is a rare, inherited disease, in which the level of a L iduronidase enzyme activity is much lower than normal. This means that substances called glycosaminoglycans (GAGs) are not broken down, so they build up in most of the organs in the body and damage them. The non-neurological symptoms of MPS I can be an enlarged liver, stiff joints that make moving more difficult, reduced lung volume, heart disease and eye disease.The medicine can only be obtained with a prescription.

How is Aldurazyme used?

Aldurazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS I or other inherited metabolic diseases. Aldurazyme should be given in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction. Aldurazyme is given once a week as an infusion into a vein. It is intended for long-term use.

How does Aldurazyme work?

The active substance in Aldurazyme, laronidase, is a copy of the human enzyme a L iduronidase. It is produced by a method known as 'recombinant DNA technology': the enzyme is made by cells into which a gene (DNA) has been introduced that makes them able to produce laronidase. Laronidase is used as 'enzyme replacement therapy', which means that it replaces the enzyme that is missing in patients with MPS I. This controls the symptoms of MPS I, improving the patient's quality of life.

How has Aldurazyme been studied?

Aldurazyme has been compared with placebo (a dummy treatment) in 45 patients aged six years and over with a confirmed diagnosis of MPS I. The main measure of effectiveness was the forced vital capacity (FVC, a measure of how well the lungs are working) and the distance the patients could walk over six minutes. These were measured before and after 26 weeks of treatment. After this, the study continued for up to four years and all of the patients were treated with Aldurazyme.Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year. The study was looking mainly at the safety of the medicine, but it also measured its ability to reduce the levels of GAGs in the urine and the size of the liver.

What benefit has Aldurazyme shown during the studies?

The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks. This effect was maintained for up to four years.In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60%. Half of the children treated had a normal size liver at the end of the study.

What is the risk associated with Aldurazyme?

Most of the side effects seen with Aldurazyme are reactions caused by the infusion procedure rather than the medicine itself. Some of these are severe, but the number of side effects tends to decrease with time. The most common side effects in patients over the age of five years (seen in more than 1 patient in 10) are headache, nausea (feeling sick), abdominal pain (stomach ache), rash, arthropathy (damage to the joints), arthralgia (joint pain), back pain, pain in the extremities (hands and feet), flushing, pyrexia (fever) and reactions at the site of the infusion. In patients under five years of age, the most common side effects (seen in more than 1 patient in 10) are increased blood pressure, decreased oxygen saturation (a measure of how well the lungs are working), tachycardia (rapid heart rate), pyrexia and chills. For the full list of all side effects reported with Aldurazyme, see the package leaflet.Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme). The effect of these on the safety and effectiveness of the medicine is not fully known.Aldurazyme must not be used in people who are severely allergic to laronidase or any of the other ingredients.

Why has Aldurazyme been approved?

The CHMP decided that Aldurazyme gives effective control of the symptoms of MPS I. The Committee decided that Aldurazyme's benefits are greater than its risks and recommended that Aldurazyme be given marketing authorisation.Aldurazyme was originally authorised under 'exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval. As the company had supplied the additional information requested, the 'exceptional circumstances' ended on 16 December 2015.


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Alecensa


What is Alecensa and what is it used for?

Alecensa is a cancer medicine used to treat adults with a lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has not been treated before or has been treated before with a cancer medicine called Xalkori (crizotinib).Alecensa is used on its own and only if the NSCLC is 'ALK-positive', which means that the cancer cells have certain defects affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).Alecensa contains the active substance alectinib.

How is Alecensa used?

Alecensa can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines. Genetic defects affecting ALK ('ALK-positive' status) should be confirmed in advance by appropriate methods.The medicine is available as capsules (150 mg). The recommended usual dose is 4 capsules taken twice a day with food (1,200 mg in total). For patients with severe liver impairment the recommended dose is 3 capsules taken twice a day with food (900 mg in total). The doctor may reduce the dose or stop treatment temporarily if side effects occur. In certain cases treatment should be permanently stopped.For more information about using Alecensa, see the package leaflet or contact your doctor or pharmacist.

How does Alecensa work?

ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. In patients with ALKpositive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion. The active substance in Alecensa, alectinib, is an ALK inhibitor and works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.

What benefits of Alecensa have been shown in studies?

Alecensa has been shown to be effective in treating ALK-positive NSCLC in three studies.Two main studies involved a total of 225 patients in whom the disease progressed despite previous treatment with Xalkori (crizotinib). In both studies Alecensa was not compared with any other treatment or placebo (a dummy treatment). Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.In the first study around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis. In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients). Response was maintained for an average of 14.9 months in the first study, and 15.2 months in the second study.The third study involved 303 patients whose ALK-positive NSCLC had not been treated before. Alecensa was compared with Xalkori and the main measure of effectiveness was how long patients lived without their disease getting worse. After 1 year of treatment, 68% of patients receiving Alecensa lived without their disease getting worse compared with 49% of patients receiving Xalkori.

What are the risks associated with Alecensa?

The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, muscle pain and oedema (swelling) including of the ankles and feet, the face, the eyelids and the area around the eyes.For the full list of side effects and restrictions with Alecensa, see the package leaflet.

Why is Alecensa authorised in the EU?

The European Medicines Agency decided that Alecensa's benefits are greater than its risks and it can be authorised for use in the EU.Patients whose disease progresses during or shortly after treatment with Xalkori currently have very limited treatment options and Alecensa can be of benefit in these patients. Alecensa was also better than Xalkori at treating previously untreated patients with ALK-positive NSCLC. The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.

What measures are being taken to ensure the safe and effective use of Alecensa?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alecensa have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Alecensa are continuously monitored. Side effects reported with Alecensa are carefully evaluated and any necessary action taken to protect patients.


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Alimta


What is Alimta?

Alimta is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance pemetrexed.

What is Alimta used for?

Alimta is used to treat two types of lung cancer:• malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos),where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;• advanced 'non small cell' lung cancer of the kind known as 'non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received anticancer treatment. It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.The medicine can only be obtained with a prescription.

How is Alimta used?

Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient's height and weight). It is given once every three weeks as an infusion lasting 10 minutes. To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta. When Alimta is given with cisplatin, an 'anti emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects. For more information, see the summary of product characteristics (also part of the EPAR).

How does Alimta work?

The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group 'antimetabolites'. In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing 'nucleotides' (the building blocks of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying. The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This results in the division of cancer cells being reduced, while normal cells are only slightly affected.

How has Alimta been studied?

For the treatment of malignant pleural mesothelioma, Alimta in combination with cisplatin has been compared with cisplatin alone in one main study in 456 patients who had not received chemotherapy for their disease before.For the treatment of locally advanced or metastatic non small cell lung cancer, Alimta was compared with gemcitabine (another anticancer medicine), in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy before.Alimta was also compared with docetaxel (another anticancer medicine) in one study involving 571 patients who had received chemotherapy in the past. For maintenance treatment, Alimta was compared with placebo (a dummy treatment) in two main studies involving 1,202 patients whose cancer had not got worse during platinum-based chemotherapy.The main measures of effectiveness were how long the patients survived and how long they lived without their cancer getting worse.

What benefit has Alimta shown during the studies?

Alimta increased the survival time of patients with malignant pleural mesothelioma. Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.In the treatment of non small cell lung cancer, Alimta was as effective as the comparators, with survival times around 10.3 months in patients who had not received chemotherapy in the past, and around 8.1 months in those who had received chemotherapy in the past.In one maintenance treatment study, patients receiving Alimta lived for a further 4.3 months from the start of maintenance treatment without their cancer getting worse, compared with 2.6 months in thoseAlimtareceiving placebo. In the second maintenance study, the figures were 4.1 months in the Alimta and 2.8 months in the placebo group.Improved survival times with Alimta were only seen in patients with non small cell lung cancer of the non-squamous type.

What is the risk associated with Alimta?

The most common side effects with Alimta, used on its own or with other anticancer medicines, are bone marrow suppression (when the bone marrow produces less blood cells than normal) and gastrointestinal toxicities (side effects affecting the stomach and gut). Bone marrow suppression causes decreased levels in the blood of white blood cells (the cells that fight infection), platelets (components that help the blood to clot) and haemoglobin (the protein found in red blood cells that carries oxygen around the body). The gastrointestinal toxicities seen with Alimta are loss of appetite, nausea (feeling sick), vomiting, diarrhoea, constipation, pharyngitis (sore throat), and mucositis or stomatitis (inflammation of the lining of the digestive system and mouth). For the full list of all side effects reported with Alimta, see the package leaflet.Alimta must not be used in people who are hypersensitive (allergic) to pemetrexed or any of the other ingredients. It must not be used during breast-feeding or at the same time as the vaccine for yellow fever. Alimta affects fertility, so both men and women who receive it need to be made aware of this.

Why has Alimta been approved?

The CHMP concluded that Alimta's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Alkindi


What is Alkindi and what is it used for?

Alkindi is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.Cortisol is needed to control many body processes (including inflammation and the control of sugar and mineral levels) and is sometimes referred to as the 'stress hormone' because it helps the body respond to stress. A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.Alkindi is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance (in this case Hydrocortisone Tablets Auden Mckenzie), but Alkindi is available in a different form (granules instead of tablets) and has been developed for children only.Alkindi contains the active substance hydrocortisone.

How is Alkindi used?

Alkindi is available as capsules containing granules. The capsules are opened and the granules are placed in the child's mouth. The child should then be given water or milk to swallow the granules. The granules can also be sprinkled on a spoonful of soft food and given to the child immediately.The dose is chosen to be lowest possible that controls the child's symptoms. For further information, see the package leaflet.The medicine can only be obtained with a prescription.

How does Alkindi work?

The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body's adrenal gland. Hydrocortisone replaces the natural cortisol that is missing in children whose adrenal glands do not produce enough of the hormone, thereby helping to relieve their symptoms.

What benefits of Alkindi have been shown in studies?

Studies on the benefits and risks of the active substance have already been carried out with the reference medicine and do not need to be repeated for Alkindi.As for every medicine, the company provided studies on the quality of Alkindi. The company also carried out studies to show that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the risks associated with Alkindi?

No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines. These include changes in behaviour, nausea, inflammation in the lining of the stomach and changes in blood potassium levels and excess acid in the blood. For the full list of side effects see the package leaflet.Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi. It must also not be used in children with difficulty swallowing or in premature babies who haven't started feeding by mouth.

Why is Alkindi approved?

Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU. Alkindi is also available in a form suitable for children and it is easier to give a precise dose with Alkindi than with other treatments which require crushing tablets and weighing up the right dose.The European Medicines Agency concluded that the benefits of Alkindi are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Alkindi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alkindi have been included in the summary of product characteristics and the package leaflet.Alkindi


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Alli


What is Alli?

Alli is a medicine that contains the active substance orlistat. It is available as capsules (60 mg) and as chewable tablets (27 mg).

What is Alli used for?

Alli is used to help patients lose weight. It is used in adults who are overweight with a body mass index (BMI) greater than or equal to 28 kg per square metre, in combination with a low calorie diet with reduced fat levels.The medicine can be obtained without a prescription.

How is Alli used?

One Alli capsule or chewable tablet is taken just before, during, or up to one hour after each main meal, three times a day. If a meal is missed or contains no fat, Alli should not be taken. The patient should be on a diet in which about 30% of the calories come from fat. The food in the diet should be spread over three main meals. Alli should not be taken for more than six months.Patients taking Alli should start a diet and exercise regime before beginning treatment. If patients taking Alli have been unable to lose weight after 12 weeks, they should speak to their doctor or pharmacist. It may be necessary to stop treatment.1 Previously known as Orlistat GSK.

How does Alli work?

The active substance in Alli, orlistat, is an anti-obesity medicine, which does not affect appetite. Orlistat blocks gastrointestinal lipases (enzymes that digest fat). When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested. The body does not absorb this fat and this helps the patient reduce their weight.

How has Alli been studied?

Because Alli is based on another medicine containing the same active substance already authorised in the EU (Xenical 120 mg capsules), some of the studies involved patients who took Xenical.Alli capsules have been studied in three main studies. Two of the studies involving a total of 1,353 overweight or obese patients with a BMI of 28 kg/m2 or more and lasted from one to two years, comparing Alli given at different doses with placebo (a dummy treatment), in combination with dieting. Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study. The third study compared Alli with placebo in 391 overweight patients with a BMI between 25 and 28 kg/m2. The study lasted four months.In all of the studies, the main measure of effectiveness was the change in weight.The company also carried out studies to show that Alli 27 mg chewable tablets have the same effect on fat absorption as Alli 60 mg capsules.

What benefit has Alli shown during the studies?

Alli was more effective than placebo in reducing weight in patients with a BMI of 28 kg/m2 or more. In the two studies of patients with a BMI of 28 kg/m2 or more, patients taking Alli 60 mg capsules had lost an average of 4.8 kg after a year, compared with 2.3 kg in those taking placebo.The study of Alli in patients with a BMI between 25 and 28 kg/m2 failed to show a degree of weight loss that would be relevant for patients.The studies comparing the chewable tablets with the capsules showed that the amount of undigested fat passed out in patients' stools was the same after taking either formulation.

What is the risk associated with Alli?

Most of the side effects with Alli affect the digestive system and are less likely to occur with a low fat diet. In general, they are mild, and occur at the beginning of treatment, going away after some time. The most common side effects with Alli (seen in more than 1 patient in 10) are oily spotting, flatus(gas) with discharge, faecal urgency (urgent need to open the bowels), fatty oily stool, oily evacuation (bowel movements of just oil, without stool), flatulence (gas) and soft stools. For the full list of all side effects reported with Alli, see the package leaflet.Alli must not be used in people who are hypersensitive (allergic) to orlistat or any of the other ingredients. It must not be used in people who are being treated with ciclosporin (used to prevent organ rejection in transplant patients) or with medicines used to prevent blood clots such as warfarin. It must also not be used in people with chronic malabsorption syndrome (a long-term disease where nutrients from food are not easily absorbed during digestion) or cholestasis (a liver disorder), or in women who are pregnant or breast-feeding.AlliF

Why has Alli been approved?

The CHMP decided that the benefits of Alli are greater than its risks and recommended that it be given marketing authorisation.


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Alofisel


What is Alofisel and what is it used for?

Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease (an inflammatory condition of the gut) when a conventional or biological medicine has not worked well enough.Fistulas are abnormal passages between the lower parts of the gut and the skin near the anus. Complex fistulas are those with several abnormal passages and openings, or with passages that go deep inside the body, or where there are other complications such as collection of pus.Alofisel contains the active substance darvadstrocel, which comprises stem cells removed from fat tissue of adult donors. It is a type of advanced therapy medicine called a 'somatic cell therapy product'. This is a type of medicine that contains cells or tissues that have been modified so that they can be used to cure, diagnose or prevent a disease.Because the number of patients with anal fistula is low, the disease is considered 'rare', and Alofisel was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 October 2009.

How is Alofisel used?

Alofisel should be given only by specialist doctors experienced in the diagnosis and treatment of the condition for which it is used. The medicine can only be obtained with a prescription.Alofisel is given just once. The patient is given an anaesthetic (either to put the patient to sleep or to numb the treatment area). After preparing the fistulas for treatment in an operating room, the contents of two vials (each containing 30 million cells) are injected around the internal openings and two further vials through the external openings into the walls of the fistula.For further information, see the package leaflet.

How does Alofisel work?

Alofisel is made up of 'mesenchymal stem cells' from the fat tissue of a donor. To make this medicine, the cells are selected and cultivated in the laboratory to increase their number. When injected into the walls of the fistula, these cells can help to reduce inflammation and support the growth of new tissue. This encourages the fistula to heal and close.

What benefits of Alofisel have been shown in studies?

One main study, involving 212 patients with Crohn's disease and complex anal fistulas, found Alofisel more effective than placebo (a dummy treatment) 24 weeks after treatment. Treatment with conventional or biological medicines had not worked in these patients. The main measure of effectiveness, called 'combined remission', was the closing of abnormal external openings together with lack of fluid collections of more than 2 cm associated with internal passages (since these are likely to re-open the fistula). Of the patients treated with Alofisel, combined remission occurred in almost 50% of patients (53 out of 107); this compared with 34% of patients (36 out of 105) receiving placebo.

What are the risks associated with Alofisel?

The most common side effects with Alofisel (which may affect up to 1 in 10 people) are anal abscess (a swollen area with a collection of pus), proctalgia (anal pain), anal fistula and pain during treatment.Alofisel must not be used in patients with hypersensitivity (allergy) to bovine serum (the clear liquid in blood from cattle) or to any of the ingredients of Alofisel.

Why is Alofisel approved?

The European Medicines Agency decided that Alofisel's benefits are greater than its risks and recommended that it be approved for use in the EU. Alofisel is of value in the treatment of complex anal fistulas that have not responded well to other treatments. Data on the safety of Alofisel are limited but they provide enough information on the pattern of side effects.

What measures are being taken to ensure the safe and effective use of Alofisel?

The company that markets Alofisel will provide educational material for healthcare professionals on how to give the medicine correctly and on the possibility of passing on an infection to the patient. The company will also complete a study to continue to collect information on the effectiveness and safety of Alofisel.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alofisel have also been included in the summary of product characteristics and the package leaflet.Alofisel


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Aloxi


What is Aloxi?

Aloxi is a medicine that contains the active substance palonosetron. It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).

What is Aloxi used for?

Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). The solution for injection is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin). The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.The medicine can only be obtained with a prescription.

How is Aloxi used?

Aloxi should only be given before chemotherapy. The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy. In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms. It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting). In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.For more information, see the package leaflet.

How does Aloxi work?

The active substance in Aloxi, palonosetron, is a '5HT3 antagonist'. This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut. When 5HT attaches to these receptors, it normally causes nausea and vomiting. By blocking these receptors, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.

How has Aloxi been studied?

Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting. Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.All of the studies measured the number of patients who did not vomit after receiving chemotherapy.

What benefit has Aloxi shown during the studies?

Aloxi solution for injection was as effective as the comparator medicines. With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221). With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185). When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of 191).In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting. However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.Aloxi

What is the risk associated with Aloxi?

The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache. With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100. For the full list of all side effects and restrictions with Aloxi, see the package leaflet.

Why has Aloxi been approved?

The CHMP decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Aloxi?

A risk management plan has been developed to ensure that Aloxi is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aloxi, including the appropriate precautions to be followed by healthcare professionals and patients.


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Alprolix


What is Alprolix and what is it used for?

Alprolix is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX. It can be used in patients of all ages.Because the number of patients with haemophilia B is low, the disease is considered 'rare', and Alprolix was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 June 2007.Alprolix contains the active substance eftrenonacog alfa.

How is Alprolix used?

Alprolix can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and frequency of treatment depend on the patient's bodyweight and whether Alprolix is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health. For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).Patients or their carers may be able to inject Alprolix themselves at home once they have been trained appropriately. For full details, see the package leaflet.

How does Alprolix work?

Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Alprolix, eftrenonacog alfa, works in the body in the same way as human factor IX. It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.

What benefits of Alprolix have been shown in studies?

Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B.In the first study involving 123 adults and adolescents aged 12 years or above, patients given Alprolix as a weekly preventive treatment had around 3 bleeding episodes a year, patients given Alprolix as an every 10 days preventive treatment had around 2 bleeding episodes per year, and patients given Alprolix for treating bleedings on demand had around 18 bleeding episodes a year. In addition, when bleeding did occur, around 90% of bleeding episodes resolved with one injection of Alprolix.In the second study in 30 children aged below 12 years, Alprolix was similarly effective: 2 bleeding episodes occurred per year on average and around 75% of bleeding episodes resolved with one injection.

What are the risks associated with Alprolix?

Hypersensitivity (allergic) reactions are seen rarely with Alprolix and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control. Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.For the full list of all side effects and restrictions with Alprolix, see the package leaflet.

Why is Alprolix approved?

Studies show that Alprolix is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products. The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Alprolix's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Alprolix?

A risk management plan has been developed to ensure that Alprolix is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Alprolix, including the appropriate precautions to be followed by healthcare professionals and patients.Alprolix


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Alunbrig


What is Alunbrig and what is it used for?

Alunbrig is a cancer medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used in patients who have not been treated before with a medicine of the ALK inhibitor class or who have been treated before with the ALK-inhibitor crizotinib.Alunbrig is only used if the NSCLC is 'ALK-positive', which means that the cancer cells have certain changes affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).Alunbrig contains the active substance brigatinib.

How is Alunbrig used?

Alunbrig can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines. The patient's cancer should be tested before starting treatment to confirm it has the gene changes affecting ALK ('ALK-positive' status).The medicine is available as tablets (30 mg, 90 mg and 180 mg). The recommended starting dose is 90 mg taken once a day for the first 7 days and then increased to 180 mg once a day afterwards. Reduced doses are recommended in patients with severely reduced liver or kidney function. Patients with severely reduced kidney function should be closely monitored especially during the first week of treatment for symptoms of lung disease such as cough or difficulty breathing.Treatment can continue for as long as the patient benefits from it. The doctor may reduce the dose or stop treatment temporarily if side effects occur. In certain cases, treatment should be permanently stopped.For more information about using Alunbrig, see the package leaflet or contact your doctor or pharmacist.

How does Alunbrig work?

ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them. In patients with ALK-positive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in anSend us a questiouncontrolled fashion. The active substance in Alunbrig, brigatinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.

What benefits of Alunbrig have been shown in studies?

Alunbrig has been shown to be effective in treating ALK-positive NSCLC in two main studies.The first study involved 222 patients in whom the disease progressed despite previous treatment with crizotinib. Alunbrig was not compared with any other treatment or placebo (a dummy treatment). Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer. Out of patients who received 90 mg Alunbrig a day and increased to 180 mg after 7 days, around 56% showed a complete or partial response to the medicine. Responses were maintained on average for around 14 months.The second study involved 275 patients who had not previously been treated with an ALK inhibitor. In this study, it took 24 months on average for the disease to get worse in patients who received Alunbrig, compared with 11 months in patients who received crizotinib.

What are the risks associated with Alunbrig?

The most common side effects with Alunbrig (which may affect more than 1 in 4 people) are hyperglycaemia (high blood sugar levels), hyperinsulinaemia (high blood insulin levels), anaemia (low red blood cell counts), nausea (feeling sick), low white blood cell counts including decreased levels of the white blood cells called lymphocytes, diarrhoea, tiredness, cough, headache, hypophosphataemia (low blood levels of phosphates), rash, vomiting, dyspnoea (difficulty breathing), hypertension (high blood pressure), myalgia (muscle pain), and blood test results indicating abnormalities of liver (increased levels of ALT and AST and alkaline phosphatase), pancreas (increased lipase and amylase), muscle function (increased CPK) or blood clotting (increased APTT).The most common serious side effects (which may affect more than 1 in 50 people) are pneumonitis (inflammation in the lungs), pneumonia (infection of the lungs), dyspnoea and pyrexia (fever).For the full list of side effects and restrictions with Alunbrig, see the package leaflet.

Why is Alunbrig authorised in the EU?

Alunbrig was effective in treating patients with ALK-positive NSCLC who had been previously treated with an ALK-inhibitor medicine called crizotinib or who had not been treated with an ALK-inhibitor. Once appropriate measures are taken to manage the potentially serious side effect of lung disease, the safety profile of Alunbrig is considered manageable. The European Medicines Agency decided that Alunbrig's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Alunbrig?

The company that markets Alunbrig will submit the results of an ongoing study on the effectiveness and safety of Alunbrig in patients with ALK-positive NSCLC who have not received previous treatment targeted to ALK. It will also provide an alert card for patients summarising key safety information about the risk of lung disease with the medicine and what to do in case of signs and symptoms.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alunbrig have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Alunbrig are continuously monitored. Side effects reported with Alunbrig are carefully evaluated and any necessary action taken to protect patients.


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Alymsys


What is Alymsys and what is it used for?

Alymsys is a cancer medicine that is used to treat adults with the following cancers:• cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;• breast cancer that has spread to other parts of the body;• a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Alymsys can be used in non-small cell lung cancer unless the cancer originates in cells called squamous cells;• cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;• cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb, and the peritoneum, the membrane that lines the abdomen) that is advanced or has come back after treatment;• cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or has spread to other parts of the body.Alymsys is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.Alymsys is a 'biosimilar medicine'. This means that Alymsys is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Alymsys is Avastin. For more information on biosimilar medicines, see here.Alymsys contains the active substance bevacizumab.

How is Alymsys used?

Alymsys can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.Alymsys is given by infusion (drip) into a vein. The first infusion of Alymsys should last 90 minutes, but subsequent infusions may be given more quickly if the earlier infusion has not caused unacceptableside effects. The dose depends on the patient's weight, the type of cancer being treated and the other cancer medicines being used. Treatment is continued for as long as the patient benefits from it. The doctor may interrupt or stop treatment if the patient develops certain side effects.For more information about using Alymsys, see the package leaflet or contact your doctor or pharmacist.

How does Alymsys work?

The active substance in Alymsys, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes new blood vessels grow. By attaching to VEGF, Alymsys stops its effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.

What benefits of Alymsys have been shown in studies?

Laboratory studies comparing Alymsys with Avastin have shown that the active substance in Alymsys is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Alymsys produces similar levels of the active substance in the body to giving Avastin.In addition, a study involving 627 patients with advanced non-small cell lung cancer showed thatAlymsys was as effective as Avastin when given with the cancer medicines paclitaxel and carboplatin. The cancer responded to treatment in 40% of those given Alymsys and 45% of those given Avastin, which was considered comparable.Because Alymsys is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Alymsys.

What are the risks associated with Alymsys?

The safety of Alymsys has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Avastin.The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Alymsys, see the package leaflet.Alymsys must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant (genetically engineered) antibodies. It must not be given to pregnant women.

Why is Alymsys authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Alymsys has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way. In addition, studies in non-small cell lung cancer have shown that the safety and effectiveness of Alymsys is equivalent to that of Avastin in this indication.All these data were considered sufficient to conclude that Alymsys will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Avastin, the benefits of Alymsys outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Alymsys?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alymsys have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Alymsys are continuously monitored. Side effects reported with Alymsys are carefully evaluated and any necessary action taken to protect patients.


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Ambirix


What is Ambirix?

Ambirix is a vaccine that contains inactivated (killed) hepatitis A virus and parts of the hepatitis B virus as active substances. It is available as a suspension for injection.

What is Ambirix used for?

Ambirix is used to protect against hepatitis A and hepatitis B (diseases that affect the liver) in children between one and 15 years of age who are not already immune to these two diseases.Ambirix is used as a two-dose schedule and protection against hepatitis B may not be obtained until after the second dose. Because of this, Ambirix should only be used when there is a low risk of hepatitis B infection during the vaccination course, and when it is certain that the two-dose vaccination course can be completed.The medicine can only be obtained with a prescription.

How is Ambirix used?

Ambirix is given as two injections six to 12 months apart into the muscle of the upper arm, or into the thigh in very young children. Individuals who receive the first injection should complete the course with Ambirix.Where a booster dose of hepatitis A or B is desired, Ambirix, or a separate hepatitis A or B vaccine may be given.

How does Ambirix work?

Ambirix is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Ambirix contains small amounts of inactivated hepatitis A viruses and the 'surface antigen' (proteins from the surface) of the hepatitis B virus. When a child is given the vaccine, the immune system recognises the viruses and surface antigens as 'foreign' and makes antibodies against them., The immune system will then be able to make antibodies more quickly when exposed to the viruses again. The antibodies will help to protect against the diseases caused by these viruses.The vaccine is 'adsorbed'. This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response. The surface antigens of the hepatitis B virus are produced by a method known as 'recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.The active substances in Ambirix have been available in other vaccines authorised in the EuropeanUnion (EU): Ambirix contains the same ingredients as Twinrix Adult, which has been authorised since 1996, and as Twinrix Paediatric, which has been authorised since 1997. The three vaccines are used to protect against the same diseases, but Twinrix Adult and Twinrix Paediatric are given as a three-dose schedule.

How has Ambirix been studied?

Because Ambirix and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Ambirix.Three main studies of Ambirix were carried out in a total of 615 children from one year of age. All of the children received two doses of Ambirix six months apart. Two of the studies compared Ambirix with other vaccines against hepatitis A and B. The main measure of effectiveness was the proportion of vaccinated children who developed protective levels of antibodies one month after the last injection.An additional study in 208 children compared the vaccine's effectiveness when a six-month or a 12-month interval was used between the two injections.

What benefit has Ambirix shown during the studies?

Ambirix led to the development of protective levels of antibodies against hepatitis A and B in between 98 and 100% of the vaccinated children one month after the last injection. These levels were maintained in over 93% of the children after two years. Ambirix was as effective as other vaccines against hepatitis A and B once the full vaccination course had been completed. However, full protection against hepatitis B did not develop until the second dose of Ambirix had been given.The additional study showed that the levels of protection with Ambirix were similar with a six- and a12-month gap between injections.

What is the risk associated with Ambirix?

The most common side effects with Ambirix (seen in more than one in 10 doses of the vaccine) are loss of appetite, irritability, headache, fatigue (tiredness) and pain and redness at the site of injection. For the full list of all side effects reported with Ambirix, see the package leaflet.Ambirix should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). It must also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.Vaccination with Ambirix should be postponed in patients with a severe sudden fever. The vaccine should never be injected into a vein.

Why has Ambirix been approved?

The CHMP decided that Ambirix's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Ambrisentan Mylan


What is Ambrisentan Mylan and what is it used for?

Ambrisentan Mylan is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).PAH is abnormally high blood pressure in the arteries of the lungs. Ambrisentan Mylan is used in patients with class II or III disease. The 'class' reflects the severity of the disease: 'class II' involves slight limitation of physical activity and 'class III' involves marked limitation of physical activity. Ambrisentan Mylan is effective in PAH with no identified cause and in PAH caused by connective tissue disease.Ambrisentan Mylan contains the active substance ambrisentan and is a 'generic medicine'. This means that Ambrisentan Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Volibris. For more information on generic medicines, see the question-and-answer document here.

How is Ambrisentan Mylan used?

Ambrisentan Mylan can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.Ambrisentan Mylan is available as tablets (5 and 10 mg). Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient. The dose is increased to 10 mg daily when the medicine is used with tadalafil (another medicine for PAH). When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.For more information about using Ambrisentan Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Ambrisentan Mylan work?

PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces theSendflow of blood to the lungs. As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult. The active substance in Ambrisentan Mylan, ambrisentan, blocks the receptors (targets) for a hormone called endothelin, which causes blood vessels to become narrow. By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.

How has Ambrisentan Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.As for every medicine, the company provided studies on the quality of Ambrisentan Mylan. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Ambrisentan Mylan?

Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Ambrisentan Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris. Therefore, the Agency's view was that, as for Volibris, the benefit of Ambrisentan Mylan outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Ambrisentan Mylan?

The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Ambrisentan Mylan are continuously monitored. Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.


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Ameluz


What is Ameluz and what is it used for?

Ameluz is a medicine used in adults to treat mild to moderate actinic keratoses, skin growths caused by exposure to sunlight, which can lead to skin cancer. It may also be used to treat an area of suninduced skin damage with multiple actinic keratosis growths (field cancerisation).Ameluz can also be used in adults to treat certain types of basal cell carcinoma (a type of skin cancer) when it cannot be treated by surgery.Ameluz contains the active substance 5-aminolaevulinic acid.

How is Ameluz used?

Ameluz is available as a gel to be applied to the skin. It can only be obtained with a prescription and should only be given under the supervision of a healthcare professional experienced in using photodynamic therapy, which involves applying a source of light to activate the medicine.Ameluz is applied directly to the skin growths or lesions or to the entire area affected and a light source is then shone onto the skin. When treating actinic keratosis growths on the face and scalp, Ameluz can be activated by exposure to full daylight or to a red-light lamp. When treating actinic keratosis growths on other parts of the body or basal cell carcinoma lesions, a red-light lamp must be used.Single or multiple actinic keratosis growths may be treated in one session, while basal cell carcinoma lesions will need two treatment sessions about one week apart. The state of the growths or lesions should be monitored three months after treatment, and any remaining growths or lesions should be retreated.For more information about using Ameluz, see the package leaflet or contact your doctor or pharmacist.

How does Ameluz work?

When Ameluz is applied to the abnormal skin growths or lesions, the active substance in the medicine,5-aminolaevulinic acid, is absorbed by cells where it acts as a photosensitising agent (a substance thatchanges when exposed to light of a certain wavelength). When the affected skin is exposed to light, the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen. This kills the cells by reacting with and destroying their components, such as proteins and DNA.

What benefits of Ameluz have been shown in studies?

Ameluz was more effective than placebo (a dummy treatment) or a comparator medicine when used in photodynamic therapy to treat actinic keratosis or basal cell carcinoma. The effects of Ameluz were examined in five main studies in patients with actinic keratosis, and in one main study in patients with basal cell carcinoma. All studies measured whether actinic keratoses or cancer lesions had all cleared up three months after the last treatment.In the first main study involving 571 patients with actinic keratosis on their face or scalp, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used together with a red light for one or two treatment sessions. Actinic keratosis cleared up in 78% (194 out of 248) of patients treated with Ameluz, compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 76) of patients treated with placebo.In the second main study involving 122 patients with actinic keratosis on their face or scalp, Ameluz was compared with placebo used together with a red light for one or two treatment sessions. Actinic keratosis cleared up in 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.In the third study involving 87 patients with field cancerisation on their face and forehead or scalp (an area of sun damage with several actinic keratosis growths), Ameluz was compared with placebo used together with a red light for one or two treatment sessions. The condition cleared up in 91% (50 out of 55) of patients given Ameluz, compared with 22% (7 out of 32) given placebo.A further study in 52 patients with actinic keratosis on the face or scalp found that Ameluz was at least as effective as Metvix at clearing actinic keratosis when used in combination with daylight.In a study involving 50 patients with mild to severe actinic keratosis on the trunk, neck or extremities (legs or arms), Ameluz and placebo were applied to the skin in different areas of the body, followed by exposure to a red light. On average, 86% of actinic keratosis growths cleared up in the areas treated with Ameluz compared with 33% in the area treated with placebo.For basal cell carcinoma that cannot be treated surgically, Ameluz was investigated in a study involving 281 patients, in which it was compared with Metvix. Ameluz was at least as effective as Metvix in this study, with cancerous lesions clearing up in 93% (113 out of 121) of patients treated with Ameluz and 92% (101 out of 110) of those treated with the comparator medicine.

What are the risks associated with Ameluz?

The most common side effects with Ameluz (which may affect more than 1 in 10 people) are reactions at the site of application, including erythema (reddening of the skin), pain (including burning pain), irritation, itching, oedema (swelling), scab formation, exfoliation (skin peeling), hardening of the skin and paraesthesia (sensations like numbness, tingling, pins and needles). For the full list of side effects of Ameluz, see the package leaflet.Ameluz must not be given to people who are hypersensitive (allergic) to 5-aminolaevulinic acid, porphyrins, soybeans or peanuts, or any of the ingredients. It must not be used in people who haveporphyria (an inability to break down chemicals called porphyrins) or people who have certain skin diseases caused by exposure to light or which can get worse when the skin is exposed to sunlight, such as lupus erythematosus. For the full list of restrictions, see the package leaflet.

Why is Ameluz authorised in the EU?

The European Medicines Agency concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative. The Agency therefore concluded that the benefits of Ameluz are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Ameluz?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ameluz have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Ameluz are continuously monitored. Side effects reported with Ameluz are carefully evaluated and any necessary action taken to protect patients.


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Amgevita


What is Amgevita and what is it used for?

Amgevita is a medicine that acts on the immune system and is used to treat the following conditions:• plaque psoriasis (a disease causing red, scaly patches on the skin)• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)• rheumatoid arthritis (a disease causing inflammation of the joints)• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation• Crohn's disease (a disease causing inflammation of the gut)• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut)• polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints)• hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin• non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).Amgevita is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. For detailed information on the use of Amgevita in all conditions, including when it can be used in children, see the summary of product characteristics (also part of the EPAR).Amgevita contains the active substance adalimumab and is a 'biosimilar medicine'. This means that Amgevita is highly similar to a biological medicine (also known as the 'reference medicine') that is already authorised in the European Union (EU). The reference medicine for Amgevita is Humira. For more information on biosimilar medicines, see the question-and-answer document here.

How is Amgevita used?

Amgevita can only be obtained with a prescription and treatment should be started and supervised by specialist doctors experienced in the diagnosis and treatment of the conditions for which it is authorised. Doctors treating uveitis should also take advice from doctors who have experience of using Amgevita.The medicine is available as a solution for injection under the skin in a pre-filled syringe or pen. The dose depends on the condition to be treated and in children is usually calculated according to the child's weight and height. After the starting dose, Amgevita is most often given every two weeks, but it may be given every week in certain situations. After training, patients or their carers may inject Amgevita if their doctor considers it appropriate. Patients may be given other medicines during treatment with Amgevita, such as methotrexate or corticosteroids (other anti-inflammatory medicines).


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Amglidia


What is Amglidia and what is it used for?

Amglidia is a medicine used to treat newborns and children with neonatal diabetes, a form of diabetes that occurs in the first 6 months of life and that requires treatment with insulin. Amglidia was shown to be effective in patients with whose disease was caused by certain genetic mutations.Amglidia contains the active substance glibenclamide.Neonatal diabetes is rare, and Amglidia was designated an 'orphan medicine' (a medicine used in rare diseases) on 15 January 2016. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designationAmglidia is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but is available in a different formulation. While the reference medicine Daonil is given as tablets, Amglidia is available as a liquid (suspension).

How is Amglidia used?

Amglidia should be started by a specialist experienced in the treatment of patients with very early onset diabetes and can only be obtained with a prescription. The medicine is available as a liquid to be taken by mouth using a syringe. It can be used with insulin and the recommended dose depends on the child's bodyweight and blood glucose levels, and is split into two daily administrations. The dose is increased over the first 4 weeks until blood glucose levels are under control and as the dose is increased, it is usually possible to reduce and even stop the regular insulin.For more information about using Amglidia, see the package leaflet or contact your doctor or pharmacist.

How does Amglidia work?

In many newborn babies with neonatal diabetes, the cells in the pancreas produce insulin but they are not able to release it into the blood to control the level of blood glucose. The lack of insulin in the blood causes symptoms of diabetes.The active substance in Amglidia, glibenclamide, is a diabetes medicine that belongs to the class of sulfonylureas. It works on insulin-producing cells in the pancreas and attaches to channels on their surface called KATP channels, involved in triggering the release of insulin. By attaching to these channels, glibenclamide restores the cells`ability to release insulin into the blood, reducing the symptoms of diabetes.

What benefits of Amglidia have been shown in studies?

The company provided data from the published literature on glibenclamide given as crushed tablets. These data show that in patients who were switched from insulin to glibenclamide, blood glucose remained controlled over time (measured as glycosylated haemoglobin (HbA1c)).A study evaluated 10 children with neonatal diabetes who were treated with glibenclamide given as crushed tablets and who were switched to the oral suspension. Blood glucose remained under control whether patients were taking crushed tablets or oral suspension.In addition, a study involving 18 healthy adults showed that glibenclamide given as a suspension produced a similar level of glibenclamide in the body as glibenclamide given as crushed tablets.

What are the risks associated with Amglidia?

The most common side effects with Amglidia (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose levels), diarrhoea and abdominal pain (stomach ache). The most serious side effect is hypoglycaemia. For the full list of side effects of Amglidia, see the package leaflet.Amglidia must not be used in people who are hypersensitive (allergic) to glibenclamide, other sulphonylureas or any of the other ingredients. It must not be used in patients who have complications of diabetes (diabetic ketoacidosis), take the medicine bosentan, have porphyria (an inability to break down chemicals called porphyrins) or have severe problems with their liver or kidneys. For the full list of restrictions, see the package leaflet.

Why is Amglidia authorised in the EU?

Glibenclamide has been used to treat neonatal diabetes for many years, however it was not licensed for this use and an age-appropriate formulation was not available. Although limited, available data show that sulfonylureas such as glibenclamide have beneficial effects on blood glucose levels in patients with neonatal diabetes and allow their regular insulin use to be reduced or stopped. In terms of side effects, these are widely known and considered manageable. The European Medicines Agency therefore decided that Amglidia's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Amglidia?

The company that markets Amglidia will issue educational materials for healthcare professionals with detailed information on the different presentations available and how to avoid mix-ups between them.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amglidia have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Amglidia are continuously monitored. Side effects reported with Amglidia are carefully evaluated and any necessary action taken to protect patients.


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Amifampridine Serb


What is Amifampridine Serb and what is it used for?

Amifampridine Serb is a medicine used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles.Amifampridine Serb contains the active substance amifampridine and is a 'generic medicine'. This means that Amifampridine Serb contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Firdapse. For more information on generic medicines, see the question-and-answer document here.

How is Amifampridine Serb used?

Amifampridine Serb can only be obtained with a prescription and treatment with this medicine should only be started under the supervision of a doctor experienced in treating LEMS.The recommended starting dose of Amifampridine Serb is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day. Amifampridine Serb is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Amifampridine Serb should be taken with food.For more information about using Amifampridine Serb, see the package leaflet or contact your doctor or pharmacist.

How does Amifampridine Serb work?

For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine. Acetylcholine is released from the nerve endings during a period of 'depolarisation'. The active substance in Amifampridine Serb, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells. This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.Send

How has Amifampridine Serb been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Firdapse, and do not need to be repeated for Amifampridine Serb.As for every medicine, the company provided data on the quality of Amifampridine Serb. There was no need for 'bioequivalence' studies to investigate whether Amifampridine Serb is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Amifampridine Serb is the same as the reference medicine and the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Amifampridine Serb?

Because Amifampridine Serb is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Amifampridine Serb authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, AmifampridineSerb has been shown to be comparable to Firdapse. Therefore, the Agency's view was that, as for Firdapse, the benefits of Amifampridine Serb outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Amifampridine Serb?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amifampridine Serb have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Amifampridine Serb are continuously monitored. Suspected side effects reported with Amifampridine Serb are carefully evaluated and any necessary action taken to protect patients.


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Amlodipine/Valsartan Mylan


What is Amlodipine/Valsartan Mylan and what is it used for?

Amlodipine/Valsartan Mylan is a medicine used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. 'Essential' means that the hypertension has no obvious cause.Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan. It is a 'generic medicine'. This means that Amlodipine/Valsartan Mylan is similar to a 'reference medicine' already authorised in the European Union (EU) called Exforge. For more information on generic medicines, see the question-and-answer document here.

How is Amlodipine/Valsartan Mylan used?

Amlodipine/Valsartan Mylan is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan). One tablet is taken daily by mouth with water. It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet. The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.The medicine can only be obtained with a prescription.

How does Amlodipine/Valsartan Mylan work?

Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan. Both are anti- hypertensive medicines that have been available separately in the European Union (EU) since the mid1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells through which calcium normally enters the cells. When calcium enters the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.Valsartan is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

How has Amlodipine/Valsartan Mylan been studied?

Because Amlodipine/Valsartan Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exforge. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Amlodipine/Valsartan Mylan?

Because Amlodipine/Valsartan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Amlodipine/Valsartan Mylan approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge. Therefore, the CHMP's view was that, as for Exforge, the benefit outweighs the identified risk. The Committee recommended that Amlodipine/Valsartan Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Amlodipine/Valsartan Mylan?

A risk management plan has been developed to ensure that Amlodipine/Valsartan Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Amlodipine/Valsartan Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.


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Ammonaps


What is Ammonaps?

Ammonaps is a medicine that contains the active substance sodium phenylbutyrate. It is available as white oval tablets (500 mg) and as granules (940 mg/g).

What is Ammonaps used for?

Ammonaps is used to treat patients who have urea cycle disorders. These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver. In the body, waste nitrogen is in the form of ammonia, which is toxic, especially for the brain. Ammonaps is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase. It can be used in patients with the following forms of the disease:• 'early-onset' disease in babies who show a complete lack of one or more of these enzymes within the first month of life;• 'late-onset' disease in patients who show a partial lack of an enzyme after the age of one month and have had brain damage caused by high blood ammonia levels. The medicine can only be obtained with a prescription.

How is Ammonaps used?

Ammonaps treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.Ammonaps is used as an add-on to other treatments and with a special low-protein diet to reduce the intake of nitrogen. The daily dose of Ammonaps is adjusted for each patient individually and depends on the patient's diet, height and weight. Regular blood tests are needed to find the correct daily dose.The dose of Ammonaps should be divided into equal amounts and given with each meal.The tablets are for adults and children, and the granules are used in babies and in patients who cannot swallow tablets. The granules are either mixed into food or drink immediately before being taken, or dissolved in water before being given through a tube leading through the tummy or nose to the stomach.Ammonaps is a long-term treatment and needs to be taken until the patient has a successful liver transplant.

How does Ammonaps work?

Eating protein brings nitrogen into the body, which is then transformed into ammonia. Patients with urea cycle disorders cannot get rid of ammonia from the body, so it can reach high levels, leading to serious problems including disability, brain damage and death. The active substance in Ammonaps, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body. Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys. This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.

How has Ammonaps been studied?

Ammonaps has been studied in 82 patients with urea cycle disorders who were treated with Ammonaps and had not received other treatments for their disease before. Ammonaps was not compared with any other treatments. The main measure of effectiveness was survival, but the study also looked at the number of hyperammonaemic episodes (periods of very high blood ammonia levels), cognitive development (development of the ability to think, learn and remember), growth, and blood ammonia and glutamine levels.

What benefit has Ammonaps shown during the studies?

The overall survival rate was about 80% in newborn babies who received Ammonaps. In contrast, untreated newborns usually die within the first year of life. The survival rate was higher in patients who had developed the disease later in life. Early diagnosis and immediate treatment are important to reduce the risk of disability.

What is the risk associated with Ammonaps?

The most common side effects with Ammonaps (seen in more than 1 patient in 10) are amenorrhoea (absence of periods) and irregular menstruation (irregular periods), but these only occur in fertile female patients. Other common side effects include abnormal kidney function and blood cell counts (red cells, white cells and platelets). For the full list of all side effects reported with Ammonaps, see the Package Leaflet.Ammonaps should not be used in people who may be hypersensitive (allergic) to sodium phenylbutyrate or any of the other ingredients. It must not be used in patients who are pregnant or breast-feeding.

Why has Ammonaps been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that urea cycle disorders are a serious disease with few treatments available, and that Ammonaps has been shown to prevent ammonia levels becoming too high. Therefore, despite the limited information available, the CHMP decided that Ammonaps's benefits are greater than its risks as adjunctive therapy in the chronic management of urea cycle disorders. The Committee recommended that Ammonaps be given marketing authorisation.Ammonaps was authorised under 'Exceptional Circumstances', because, as the disease is rare, limited information was available at the time of approval. As the company had supplied the additional information requested, the 'Exceptional Circumstances' ended on 6 July 2004.


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Amsparity


What is Amsparity and what is it used for?

Amsparity is a medicine that acts on the immune system (the body's natural defences) and is used to treat the following conditions:• plaque psoriasis (a disease causing red, scaly patches on the skin);• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);• rheumatoid arthritis (a disease causing inflammation of the joints);• polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis (both rare diseases causing inflammation in the joints);• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there are clear signs of inflammation but X-ray does not show disease;• Crohn's disease (a disease causing inflammation of the gut);• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);• hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;• non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).Amsparity is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Amsparity in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.Amsparity contains the active substance adalimumab and is a 'biosimilar medicine'. This means that Amsparity is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Amsparity is Humira.

How is Amsparity used?

Amsparity is available for injection under the skin in a vial or pre-filled syringe or pen and is usually given every 2 weeks. The dose and frequency of injection depend on the condition to be treated and the dose for a child is usually calculated according to the child's weight. After training, patients or their carers may inject Amsparity if their doctor considers it appropriate.Amsparity can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Amsparity is used. Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.For more information about using Amsparity, see the package leaflet or contact your doctor or pharmacist.

How does Amsparity work?

The active substance in Amsparity, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to attach to a substance in the body called tumour necrosis factor (TNF). TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Amsparity is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.

What benefits of Amsparity have been shown in studies?

Laboratory studies comparing Amsparity with the reference medicine Humira have shown that the active substance in Amsparity is highly similar to that in Humira in terms of structure, purity and biological activity. Studies have also shown that giving Amsparity produces similar levels of the active substance in the body to giving Humira.In addition, a main study involving 597 patients with moderate to severe active rheumatoid arthritis whose disease had not responded well enough to methotrexate has shown that Amsparity is as effective as Humira in reducing symptoms of the disease. The study compared the two medicines, each given with methotrexate. After 12 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 68% (203 of 297 patients) with Amsparity and 71% (214 of 300 patients) with Humira.Because Amsparity is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Amsparity.

What are the risks associated with Amsparity?

The safety of Amsparity has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Humira. The most common side effects with adalimumab (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.Like other medicines of its class, Amsparity may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.Other rare serious side effects of adalimumab (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions(where the immune system attacks the patient's own tissues, causing inflammation and organdamage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).Amsparity must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).For the full list of side effects and restrictions with Amsparity, see the package leaflet.

Why is Amsparity authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Amsparity has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. In addition, a study in rheumatoid arthritis has shown that the effectiveness of Amsparity is equivalent to that of Humira.All these data were considered sufficient to conclude that Amsparity will behave in the same way as Humira in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Humira, the benefits of Amsparity outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Amsparity?

Patients treated with Amsparity must be given a reminder card with information on the safety of the medicine.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amsparity have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Amsparity are continuously monitored. Side effects reported with Amsparity are carefully evaluated and any necessary action taken to protect patients.


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Amversio


What is Amversio and what is it used for?

Amversio is a medicine used to treat homocystinuria, an inherited disease where the amino acid homocysteine cannot be broken down and therefore builds up in the body. This causes a wide range of symptoms, including impaired vision, weak bones and circulatory problems.It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet.Amversio is a 'generic medicine'. This means that Amversio contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Cystadane. For more information on generic medicines, see the question-and-answer document here.Amversio contains the active substance betaine anhydrous.

How is Amversio used?

Amversio can only be obtained with a prescription. Treatment with Amversio should be supervised by a doctor who has experience in the treatment of patients with homocystinuria.Amversio is available as a powder to be taken by mouth. It should be dissolved fully in water, juice, milk, formula or food before being taken. The standard dose of Amversio is 50 mg per kilogram of body weight twice a day. The dose can be adjusted depending on the response to treatment(monitored by measuring the level of homocysteine in the blood). The aim of the treatment is to keep blood levels of homocysteine below 15 micromoles or as low as possible. This is usually achieved within a month.For more information about using Amversio, see the package leaflet or contact your doctor or pharmacist.

How does Amversio work?

Betaine is a natural substance that is extracted from sugar beet. It reduces the high homocysteine levels in the blood of patients with homocystinuria by transforming homocysteine into the amino acid methionine. This helps to improve the symptoms of the disease.Send

How has Amversio been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Cystadane, and do not need to be repeated for Amversio.As for every medicine, the company provided studies on the quality of Amversio. There was no need for 'bioequivalence' studies to investigate whether Amversio is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Amversio is a water-soluble medicine with a composition very similar to the reference medicine's and both products are therefore expected to be absorbed in the same way in the gut.

What are the benefits and risks of Amversio?

Because Amversio is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Amversio authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Amversio has been shown to be comparable to Cystadane. Therefore, the Agency's view was that, as for Cystadane, the benefits of Amversio outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Amversio?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amversio have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Amversio are continuously monitored. Suspected side effects reported with Amversio are carefully evaluated and any necessary action taken to protect patients.


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Amvuttra


What is Amvuttra and what is it used for?

Amvuttra is a medicine used to treat polyneuropathy (nerve damage) caused by hereditary transthyretin-mediated (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.Amvuttra is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient has weakness in the legs but is able to walk unaided, and stage 2, when the patient can still walk but needs help).hATTR amyloidosis is rare, and Amvuttra was designated an 'orphan medicine' (a medicine used in rare diseases) on 25 May 2018. Further information on the orphan designation can be found here.Amvuttra contains the active substance vutrisiran.

How is Amvuttra used?

Amvuttra can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with amyloidosis. Treatment should begin as early as possible after diagnosis, to avoid further progression of the disease.The medicine is available as an injection under the skin (subcutaneous) in the abdomen, thigh, or upper arm. The recommended dose is 25 mg once every 3 months. Patients should also take vitamin A supplements during treatment with Amvuttra.For patients whose disease progresses to stage 3 polyneuropathy, the doctor may continue treatment if the benefits outweigh the risks.For more information about using Amvuttra, see the package leaflet or contact your doctor or pharmacist.

How does Amvuttra work?

In patients with hATTR amyloidosis, a protein called transthyretin which circulates in the blood is defective and breaks easily. The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with the normal organ function.The active substance in Amvuttra, vutrisiran, is a 'small interfering RNA' (siRNA), a very short piece of synthetic genetic material, that has been designed to attach to and block the genetic material of the cells responsible for producing transthyretin. This reduces production of defective transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.

What benefits of Amvuttra have been shown in studies?

In one main study involving 164 patients with hATTR amyloidosis with stage 1 or 2 nerve damage, Amvuttra was shown effective at slowing down the nerve damage caused by the disease.The main measure of effectiveness was the change in the patients' nerve damage, as measured by a standard scale called 'mNIS+7', where a decreased score indicates an improvement and an increased score indicates worsening nerve damage. After 18 months of treatment, the mNIS+7 score decreased on average by around 0.5 points with Amvuttra. This was compared with an average increase of 28 points seen with placebo (a dummy treatment) in another study involving 225 patients comparing Onpattro (another hATTR amyloidosis medicine) with placebo.The study also showed that treatment with Amvuttra was at least as effective as Onpattro at reducing transthyretin levels.

What are the risks associated with Amvuttra?

The most common side effects with Amvuttra (which may affect more than 1 in 10 people) are pain in the extremities (arms and legs) and arthralgia (joint pain).For the full list of side effects of Amvuttra, see the package leaflet.

Why is Amvuttra authorised in the EU?

Amvuttra was shown to be effective at slowing down nerve damage in patients with hATTR amyloidosis with stage 1 or stage 2 nerve damage. Regarding safety, the side effects are considered manageable.The European Medicines Agency decided that Amvuttra's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Amvuttra?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amvuttra have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Amvuttra are continuously monitored. Suspected side effects reported with Amvuttra are carefully evaluated and any necessary action taken to protect patients.


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Amyvid


What is Amyvid?

Amyvid is a solution for injection that contains the active substance florbetapir (18F).

What is Amyvid used for?

Amyvid is for diagnostic use only. It is used for brain scans in adult patients with memory problems so that doctors can see whether or not they have significant amounts of β-amyloid plaques in the brain. β-amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease, Lewy body dementia and Parkinson's disease dementia) and some elderly people with no symptoms. The type of scan used with Amyvid is called positron emission tomography (PET).The medicine can only be obtained with a prescription.

How is Amyvid used?

Amyvid is given by injection into a vein about 30 to 50 minutes before obtaining an image from a PET scan. After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Amyvid.PET scans with Amyvid should only be requested by doctors skilled in the clinical management of patients with neurodegenerative diseases such as Alzheimer's and other dementias. Patients should discuss the results of their PET scan with their doctor.

How does Amyvid work?

The active substance in Amyvid, florbetapir (18F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain. When it attaches to the plaques, the radiation it emits is then seen on the PET scan, enabling doctors to know whether or not significant amount of plaques are present.A negative scan indicates sparse or no β-amyloid plaques, which means that the patient is unlikely to have Alzheimer's disease. A positive scan on its own, however, is not sufficient to make a diagnosis in patients with memory problems, as plaque deposition may be seen in patients with different types of neurodegenerative dementias as well as in elderly people with no symptoms. Doctors will therefore need to use the scans in conjunction with clinical evaluation.

How has Amyvid been studied?

The effects of Amyvid were first tested in experimental models before being studied in humans. A main study was conducted in 226 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died.The study looked at sensitivity and specificity of the scans (how reliable they were at differentiating volunteers who had significant amounts of plaques in the brain from those who did not). 106 volunteers completed the study and were included in the results.

What benefit has Amyvid shown during the studies?

PET scans with Amyvid were shown to have high specificity and sensitivity when used for identifying which patients had significant amounts of β-amyloid plaques in the brain. The specificity of the PET scans was 100% in 47 healthy volunteers, which means that all of their scans were rated as negative after being read by experts who were not aware if the scans belonged to healthy people or to patients.Among the patients, 59 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains. When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 92% and a specificity of 100%. This means that the PET scans were able to correctly identify as positive 92% of the patients who had significant amounts of plaques, and that all patients without significant plaques were correctly rated as negative.

What is the risk associated with Amyvid?

The most common side effect with Amyvid (seen in between 1 and 10 patients in 100) is headache. For the full list of all side effects reported with Amyvid, see the package leaflet. Amyvid delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.Amyvid must not be used in people who are hypersensitive (allergic) to florbetapir (18F) or any of the other ingredients.

Why has Amyvid been approved?

PET scans with Amyvid were shown to have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy. This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other neurodegenerative diseases. The Committee noted the good safety profile and non-invasive nature of the PET scans with Amyvid and concluded thatAmyvid's benefits are greater than its risks. The Committee recommended that Amyvid be given marketing authorisation.The CHMP did, however, note that, partly due to the limited effects of current treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Amyvid. In addition, the usefulness of Amyvid in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.

What measures are being taken to ensure the safe use of Amyvid?

The company that markets Amyvid will provide access to a training course for all nuclear medicine physicians expected to use this product in the EU in order to ensure accurate and reliable reading of the PET scan images.


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Anagrelide Mylan


What is Anagrelide Mylan and what is it used for?

Anagrelide Mylan is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood). 'Essential' means that the disease has no obvious cause.Anagrelide Mylan is used when the patient's current treatment does not work well enough or has unacceptable side effects, and when they are 'at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.Anagrelide Mylan contains the active substance anagrelide and is a 'generic medicine'. This means that Anagrelide Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Xagrid. Anagrelide Mylan is also a 'hybrid medicine' because it is available in an additional strength. For more information on generic and hybrid medicines, see the question-and-answer document here.

How is Anagrelide Mylan used?

Anagrelide Mylan can only be obtained with a prescription. Treatment should only be started by a doctor who has experience in treating essential thrombocythaemia.Anagrelide Mylan is available as capsules (0.5 and 1 mg). The recommended starting dose is one 0.5 mg capsule twice a day. After a week, the dose is increased every week by 0.5 mg a day, until the platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people). Results are normally seen within 2 or 3 weeks of starting treatment.The maximum recommended dose of Anagrelide Mylan is 2.5 mg at a time.

How does Anagrelide Mylan work?

Essential thrombocythaemia is a disease in which the bone marrow produces too many platelets. This puts the patient at risk of developing blood clots or bleeding problems. The active substance in Anagrelide Mylan, anagrelide, blocks the development and growth of cells in the bone marrow called 'megakaryocytes', which produce platelets. This reduces the platelet count, helping to improve symptoms in patients with the disease.

How has Anagrelide Mylan been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Xagrid, and do not need to be repeated for Anagrelide Mylan.As for every medicine, the company provided studies on the quality of Anagrelide Mylan. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Anagrelide Mylan?

Because Anagrelide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Anagrelide Mylan approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Anagrelide Mylan has been shown to have comparable quality and to be bioequivalent to Xagrid. Therefore, the Agency's view was that, as for Xagrid, the benefit outweighs the identified risk. The Agency recommended that Anagrelide Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Anagrelide Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anagrelide Mylan have been included in the summary of product characteristics and the package leaflet.


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Anoro Ellipta


What is Anoro Ellipta and what is it used for?

Anoro Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Anoro Ellipta is used for maintenance (regular) treatment.Anoro Ellipta contains the active substances umeclidinium bromide and vilanterol.

How is Anoro Ellipta used?

Anoro Ellipta can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device. Each inhalation provides 55 micrograms of umeclidinium (as umeclidinium bromide) and 22 micrograms of vilanterol.The recommended dose is one inhalation per day at the same time each day. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet or contact your doctor or pharmacist.

How does Anoro Ellipta work?

The active substances in Anoro Ellipta, umeclidinium and vilanterol, work in different ways to widen the airways and improve breathing in COPD. Vilanterol is a long-acting beta-2 adrenergic agonist. It works by attaching to beta-2 adrenergic receptors found in the muscle cells of many organs including the airways in the lungs. When inhaled, vilanterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax.Umeclidinium is a muscarinic receptor antagonist. It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium is inhaled, it also relaxes the muscles of the airways.1 Previously known as Anoro.The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.

What benefits of Anoro Ellipta have been shown in studies?

Anoro Ellipta and a higher-dose combination of umeclidinium and vilanterol (113 micrograms/22 micrograms) were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium alone or another COPD medicine called tiotropium in 5 main studies.In all 5 studies, involving over 5,600 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).Results showed that Anoro Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Anoro Ellipta also increased FEV1 by an average of up to 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Anoro Ellipta was 60, 90 and 112 ml more than with tiotropium after 24 weeks of treatment in the three studies where Anoro Ellipta was compared with tiotropium.Anoro Ellipta was also shown to improve breathlessness when compared with placebo.The higher dose combination of umeclidinium and vilanterol did not consistently lead to better improvements in lung function than Anoro Ellipta to justify its use.

What are the risks associated with Anoro Ellipta?

The most common side effects with Anoro Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.For the full list of side effects and restrictions, see the package leaflet.

Why is Anoro Ellipta authorised in the EU?

The European Medicines Agency decided that Anoro Ellipta's benefits are greater than its risks and it can be authorised for use in the EU. The Agency concluded that Anoro Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium. The Agency also noted that there were no major safety concerns with Anoro Ellipta, with side effects being manageable, although the long-term safety data so far are limited. To investigate this further the Agency recommended that a study be carried out.

What measures are being taken to ensure the safe and effective use of Anoro Ellipta?

As medicines of the same class as Anoro Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anoro Ellipta have also been included in the summary of product characteristics and the package leaflet.Anoro Ellipta0F (umeclidinium bromide / vilanterol)As for all medicines, data on the use of Anoro Ellipta are continuously monitored. Side effects reported with Anoro Ellipta are carefully evaluated and any necessary action taken to protect patients.


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Apealea


What is Apealea and what is it used for?

Apealea is a cancer medicine used to treat women with cancer of the ovary or surrounding structures (the fallopian tube that connects the ovary to the womb, or the peritoneum, the membrane that lines the abdomen).Apealea is given along with a platinum-based medicine, carboplatin, to patients whose disease responds to platinum-based cancer medicines and has come back after initial treatment.Apealea contains the active substance paclitaxel.

How is Apealea used?

Apealea is available as a powder to make up a solution for infusion (drip) into a vein. The paclitaxel in Apealea is formulated in tiny particles, called micelles, to help it dissolve in the infusion solvent. It should not be interchanged with other medicines containing paclitaxel.The medicine can only be obtained with a prescription and should be given under the supervision of a specialist in the treatment of cancer.The dose of Apealea is 250 mg per square metre (calculated based on height and body weight) and is given by infusion over about 1 hour, once every 3 weeks, for 6 cycles of treatment. Doses may be delayed or reduced by the doctor, or treatment may be stopped, if severe side effects occur; doses should also be reduced in patients with moderate or severe reduction in liver function. Patients are also treated with a platinum-based medicine, carboplatin.For more information about using Apealea, see the package leaflet or contact your doctor or pharmacist.

How does Apealea work?

The active substance in Apealea, paclitaxel, is a cancer medicine that has been used in the EU for many years. It belongs to the group of cancer medicines known as the 'taxanes'. Paclitaxel blocks astage of cell division in which the cell's internal 'skeleton' is dismantled to allow the cell to divide. By keeping this structure intact the cells cannot divide and they eventually die.

What benefits of Apealea have been shown in studies?

Apealea has been shown to be as effective as a conventional formulation of paclitaxel in one main study involving further treatment of 789 women whose ovarian, fallopian tube or peritoneal cancer had come back. Patients also received a platinum-based cancer medicine, carboplatin. The average length of time that patients lived without their disease coming back yet again was 10.3 months with Apealea, and 10.1 months with conventional paclitaxel.Supportive data from the study showed that the average time that patients lived after treatment was25.7 months among those given Apealea and 24.8 months for those given conventional paclitaxel.

What are the risks associated with Apealea?

The most common side effects with Apealea (which may affect more than 1 in 10 people) are neutropenia (low numbers of white blood cells called neutrophils), stomach and gut disorders such as diarrhoea, nausea (feeling sick) and vomiting, peripheral neuropathy (nerve damage in hands and feet), joint and muscle pain, and reactions such as redness, soreness and inflammation of the veins at the site of infusion. For the full list of side effects of Apealea, see the package leaflet.Apealea must not be used in patients who are breast feeding or those who already have low levels of neutrophils in the blood. For the full list of restrictions, see the package leaflet.

Why is Apealea authorised in the EU?

The European Medicines Agency considered that Apealea was as effective as conventional paclitaxel, and could be a valuable alternative in combination with carboplatin. While the new formulation might be associated with more infusion site reactions, and studies suggested stronger effects on blood cells and the gut, these were considered manageable and the overall benefits and risks are consistent with those of other paclitaxel medicines. The Agency therefore decided that Apealea's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Apealea?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Apealea have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Apealea are continuously monitored. Side effects reported with Apealea are carefully evaluated and any necessary action taken to protect patients.


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Apexxnar


What is Apexxnar and what is it used for?

Apexxnar is a vaccine to protect adults against pneumonia (infection of the lungs) and invasive diseases (diseases that occur when a bacterium spreads through the body) caused by the bacterium Streptococcus pneumoniae (S. pneumoniae).Apexxnar contains parts from 20 different types of S. pneumoniae.

How is Apexxnar used?

Apexxnar can only be obtained with a prescription.Apexxnar is available as a suspension for injection. It is given as a single injection into the muscle of the upper arm.For more information about using Apexxnar, see the package leaflet or contact your healthcare provider.

How does Apexxnar work?

Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Apexxnar prepares the body to defend itself against invasive disease and pneumonia caused by S. pneumoniae.Apexxnar contains small amounts of polysaccharides (a type of sugar) extracted from the 'capsule' that surrounds the S. pneumoniae bacterium. These polysaccharides have been purified, then conjugated (attached) to a carrier protein that helps the immune system to recognise them and respond in an enhanced manner. The vaccine is also adsorbed (fixed) onto an aluminium adjuvant (a substance to help strengthen the immune response to the vaccine). Apexxnar contains the polysaccharides from 20 different types of S. pneumoniae that can cause invasive disease and pneumonia.When a person is given Apexxnar, the immune system recognises the polysaccharides in the vaccine as 'foreign' and makes antibodies against them. The immune system will then be able to produceantibodies more quickly when it comes into contact with the bacteria that have those polysaccharides on their capsules. This helps to protect against the disease.

What benefits of Apexxnar have been shown in studies?

In 2 main studies, Apexxnar was shown to trigger immune responses that were comparable to those triggered by two other authorised pneumococcal vaccines (Prevenar 13, a vaccine that protects against 13 types of S. pneumoniae; Pneumovax 23, a vaccine that protects against 23 types of S.pneumoniae). Between them, Prevenar 13 and Pneumovax 23 cover the 20 types of S. pneumoniae (serotypes) targeted by Apexxnar. Apexxnar was considered to be protective against pneumococcal disease based on the known effectiveness of Prevenar 13 and Pneumovax 23.In one study conducted in around 3,000 people from 60 years of age, participants received either Apexxnar, or Prevenar 13 followed one month later by Pneumovax 23. One month after each vaccination, the levels of antibodies across the 2 groups were comparable for all but one of the serotypes included in Apexxnar. It was noted that although comparable, the antibody levels with Apexxnar were lower than with Prevenar 13 for most of the serotypes included in both vaccines.This study also included around 900 people aged between 18 and 59 years who received either Apexxnar or Prevenar 13. In the Apexxnar group, the antibody levels against the 20 different serotypes were comparable to those seen in people aged 60 to 64 years who received Apexxnar.A second study tested Apexxnar in 875 participants who were at least 65 years of age and had all received a pneumococcal vaccine before (Prevenar 13 only, Pneumovax 23 only or Prevenar 13 followed by Pneumovax 23). In this study Apexxnar triggered immune responses against all serotypes and in all groups, but the immune responses differed considerably between the three different vaccine groups. Overall, the increase in antibodies after vaccination with Apexxnar was greater in people who had previously only received Prevenar 13 compared with those who had received Pneumovax 23 or Prevenar 13 followed by Pneumovax 23.

What are the risks associated with Apexxnar?

The most common side effects with Apexxnar (which may affect more than 1 in 10 people) are pain at the injection site, muscle pain, tiredness, headache, and joint pain. These were usually mild or moderate in intensity and resolved within a few days after vaccination.Apexxnar must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients or to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).For the full list of side effects and restrictions of Apexxnar, see the package leaflet.

Why is Apexxnar authorised in the EU?

Apexxnar was found to trigger an immune response that is comparable to that seen with authorised pneumococcal vaccines; it is therefore expected to protect against pneumococcal disease. However, considering that for some serotypes the antibody levels observed were lower with Apexxnar than with the comparator vaccines, data on effectiveness are required to confirm the clinical benefits of Apexxnar. The side effects of Apexxnar are usually mild or moderate in intensity and similar to those seen with other pneumococcal vaccines.The European Medicines Agency therefore decided that Apexxnar's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Apexxnar?

The company that markets Apexxnar is required to provide the results from three studies on the longterm effectiveness of Apexxnar.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Apexxnar have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Apexxnar are continuously monitored. Suspected side effects reported with Apexxnar are carefully evaluated and any necessary action taken to protect patients.


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Apidra


What is Apidra?

Apidra is a solution for injection that contains the active substance insulin glulisine. It is supplied in vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).

What is Apidra used for?

Apidra is used to treat patients aged six years or over with diabetes, when they need insulin. The medicine can only be obtained with a prescription.

How is Apidra used?

Apidra is given by injection under the skin in the abdominal wall (tummy), the thigh or the shoulder, or by continuous infusion using an insulin pump. It should be given up to 15 minutes before or just after a meal. The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected. Patients can inject Apidra under the skin themselves. Apidra can also be injected into a vein, but this can only be done by a doctor or nurse.The patient's blood glucose (sugar) levels should be regularly tested to find the lowest effective dose. Apidra is a short-acting insulin that is used in combination with intermediate- or long-acting insulins or insulin analogues (modified forms of insulin). It may also be used in combination with antidiabetes medicines taken by mouth.

How does Apidra work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Apidra is a replacement insulin that is very similar to the insulin made by the body. The active substance in Apidra, insulin glulisine, is produced by a method known as 'recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glulisine. Insulin glulisine is very slightly different from human insulin. The difference means that insulin glulisine acts more rapidly, and has a shorter duration of action than a short-acting human insulin. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Apidra been studied?

Apidra, used in combination with a long-acting insulin, has been studied in type 1 diabetes (when the body cannot produce insulin) in two studies involving a total of 1,549 adults and in one study involving 572 children and adolescents aged between four and 17 years.In type 2 diabetes (when the body is unable to use insulin effectively), Apidra has been studied in one study involving 878 adults. In this study, Apidra was used in combination with an intermediate-acting insulin and antidiabetes medicines taken by mouth.In all four studies, Apidra was compared with other insulins or insulin analogues (regular human insulin or insulin lispro). The main measure of effectiveness was the change in levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

What benefit has Apidra shown during the studies?

Blood glucose control with Apidra was at least as effective as that with the comparator insulins. In all of the studies, the change in the level of HbA1c seen with Apidra was similar to that seen with the comparator insulins.In the first study of adults with type 1 diabetes, there was a decrease of 0.14% (from 7.60% to 7.46%) after six months, and a decrease of 0.14% for insulin lispro. Similar reductions were seen in the second study in adults, which compared Apidra with regular human insulin. In the study in children and adolescents, Apidra and insulin lispro produced similar changes in HbA1c after six months. However, there was not enough information to show whether Apidra was effective in children aged below six years.In adults with type 2 diabetes, there was a decrease in HbA1c of 0.46% after six months of Apidra, compared with 0.30% for regular human insulin.

What is the risk associated with Apidra?

The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with Apidra, see the Package Leaflet. Apidra should not be used in people who may be hypersensitive (allergic) to insulin glulisine or any of the other ingredients. It must not be used in patients who already have hypoglycaemia. Apidra doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels. The full list is available in the Package Leaflet.

Why has Apidra been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Apixaban Accord


What is Apixaban Accord and what is it used for?

Apixaban Accord is a medicine used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation. It is also used in adults to treat deep vein thrombosis (blood clot in a deep vein, usually in the leg) and pulmonary embolism (clot in a blood vessel supplying the lungs), and to prevent their reoccurrence.Additionally, Apixaban Accord is used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as having had a previous stroke, having high blood pressure, diabetes, heart failure or being 75 years old or over.Apixaban Accord contains the active substance apixaban.Apixaban Accord is a 'generic medicine'. This means that Apixaban Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Eliquis. For more information on generic medicines, see the question-and-answer document here.

How is Apixaban Accord used?

Apixaban Accord can only be obtained with a prescription. It is available as tablets to be taken by mouth.The dose and duration of treatment depends on the condition the medicine is being used to treat or prevent; for patients with atrial fibrillation, the dose depends on age, bodyweight and level of creatinine in the blood.For more information about using Apixaban Accord, see the package leaflet or contact your doctor or pharmacist.

How does Apixaban Accord work?

Patients undergoing hip or knee replacement surgery, who have had a recent trauma, or are confined to bed are at a high risk of blood clots forming in the veins, which can be dangerous and even fatal if these clots move to another part of the body such as the lungs. Similarly, patients with atrialSendfibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke.The active substance in Apixaban Accord, apixaban, is a 'factor Xa inhibitor'. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, apixaban reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.

How has Apixaban Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Eliquis, and do not need to be repeated for Apixaban Accord.As for every medicine, the company provided studies on the quality of Apixaban Accord. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Apixaban Accord?

Because Apixaban Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Apixaban Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Apixaban Accord has been shown to be comparable to Eliquis. Therefore, the Agency's view was that, as for Eliquis, the benefits of Apixaban Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Apixaban Accord?

The company that markets Apixaban Accord will provide educational material for healthcare professionals expected to prescribe Apixaban Accord that addresses the risk of bleeding during treatment.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Apixaban Accord have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Apixaban Accord are continuously monitored. Side effects reported with Apixaban Accord are carefully evaluated and any necessary action taken to protect patients.


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Apretude


What is Apretude and what is it used for?

Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms.Apretude contains the active substance cabotegravir.

How is Apretude used?

The medicine can only be obtained with a prescription and treatment should be prescribed by a healthcare professional who has experience in the management of HIV PrEP.Apretude is available as tablets and as a prolonged-release injection. 'Prolonged release' means that the active substance is released slowly over a few weeks after being injected. The injection must be given by a healthcare professional. It is given once a month for the first 2 injections, and then every 2 months.Alternatively, people may start with the tablets, which are taken once a day for 1 month. Use of the tablets is expected to allow quicker recovery in case of side effects. If the tablets are tolerated without side effects, the individual should be switched to the injection after 1 month.For more information about using Apretude, see the package leaflet or contact your doctor or pharmacist.

How does Apretude work?

Cabotegravir is an integrase inhibitor. It blocks an enzyme called integrase that the HIV-1 virus needs to make new copies of itself in the body. In case of exposure to the virus this will reduce the risk of the virus multiplying and spreading from the site of infection.

What benefits of Apretude have been shown in studies?

Two main studies have evaluated Apretude for pre-exposure prophylaxis. In one study Apretude was compared with standard PrEP (tenofovir disoproxil fumarate/emtricitabine) in HIV-negative cisgendermen and transgender women who have sex with men. Of 2,278 people who took Apretude, 12 tested positive for HIV-1 infection around 3 years (153 weeks) after treatment. This compared with 39 out of 2,281 people who took the standard treatment.The second study involved over 3,200 HIV-negative cisgender women and compared Apretude with standard PrEP (tenofovir disoproxil fumarate/emtricitabine). Of the individuals taking Apretude, 3 out of 1,613 tested positive for HIV-1 infection 1 year after treatment compared with 36 out of 1,610 of those taking standard PrEP.

What are the risks associated with Apretude?

For the full list of side effects and restrictions with Apretude, see the package leaflet.The most common side effects with Apretude (which may affect more than 1 in 10 people) include injection site reactions, headache, diarrhoea and increase in the liver enzyme transaminase.Apretude must not be used in people who have not been tested for HIV infection or who are positive for HIV infection. Apretude must also not be used together with some other medicines such as rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarbital.

Why is Apretude authorised in the EU?

The main studies showed that Apretude is effective at reducing the risk of HIV infection and overall it was well tolerated. Injection site reactions were generally mild and their risk decreased over duration of use. More serious side effects resulting in altered thinking or behaviour have been uncommonly reported in people with a pre-existing psychiatric disease and are managed with recommendations for counselling before and during treatment.The European Medicines Agency therefore decided that Apretude's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Apretude?

The company that markets Apretude will provide a guide to doctors and individuals who use the medicine with information about the use of Apretude. Healthcare professionals will also receive a checklist to follow when prescribing and using the medicine and a reminder card to hand out to individuals receiving Apretude for PrEP.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Apretude have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Apretude are continuously monitored. Suspected side effects reported with Apretude are carefully evaluated and any necessary action taken to protect patients.


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Aprovel


What is Aprovel?

Aprovel is a medicine that contains the active substance irbesartan. It is available as tablets (75, 150 and 300 mg).

What is Aprovel used for?

Aprovel is used in adults who have essential hypertension (high blood pressure). 'Essential' means that the hypertension has no obvious cause. Aprovel is also used to treat kidney disease in adults with hypertension and type 2 diabetes. The medicine can only be obtained with a prescription.

How is Aprovel used?

The usual recommended dose of Aprovel is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.In patients with hypertension and type 2 diabetes, Aprovel is added to some other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

How does Aprovel work?

The active substance in Aprovel, irbesartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

How has Aprovel been studied?

Aprovel was originally studied in 11 trials for its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. Its use in combination with hydrochlorothiazide was also examined in 1,736 patients. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).For the treatment of kidney disease, Aprovel was studied in two large studies involving a total of 2,326 patients with type 2 diabetes. Aprovel was used for two years or more. One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine. The second study looked at whether Aprovel increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died. In this study, Aprovel was compared with placebo and with amlodipine.

What benefit has Aprovel shown during the studies?

In the blood pressure studies, Aprovel was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. When used with hydrochlorothiazide, the effects of the two medicines were additive.In the first kidney disease study, Aprovel was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion. In the second kidney disease study, Aprovel reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo. There was a 23% relative risk reduction compared with amlodipine. The main benefit was on the effect on blood creatinine levels.

What is the risk associated with Aprovel?

The most common side effect with Aprovel (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels). For the full list of all side effects reported with Aprovel, see the package leaflet.Aprovel must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Aprovel in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.

Why has Aprovel been approved?

The CHMP decided that Aprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Aptivus


What is Aptivus?

Aptivus is a medicine that contains the active substance tipranavir. It is available as capsules (250 mg) and as an oral solution.

What is Aptivus used for?

Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.Aptivus should only be used in patients who have no other treatment options. It is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many other medicines in the same class as Aptivus (protease inhibitors) do not work. Doctors should only prescribe Aptivus once they have looked at the HIV-medicines that the patient has taken before and the likelihood that the virus will respond to the medicine.The medicine can only be obtained with a prescription.

How is Aptivus used?

Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day. Children aged between two and 12 years should use the oral solution. The dose of the oral solution depends on body surface area (calculated using the child's height and weight). Each dose of Aptivus must be taken with ritonavir and food. For more information, see the package leaflet.

How does Aptivus work?

The active substance in Aptivus, tipranavir, is a protease inhibitor. It blocks an enzyme called protease that is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection. Ritonavir is another protease inhibitor that is used as a 'booster'. It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood. This allows a lower dose of tipranavir to be used for the same antiviral effect.Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Aptivus does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Aptivus been studied?

Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had received many different HIV-medicines in the past, and were not responding to their current treatment combination including a protease inhibitor. Both studies compared the effects of Aptivus with those of another protease inhibitor that was chosen on the basis of the patient's previous treatments and predicted response. The main measures of effectiveness were the number of patients who responded to treatment, and how long it took before treatment stopped working, during the first 48 weeks of treatment. A 'response' was defined as a fall in the levels of HIV in the blood (viral load) by 90% or more that was maintained until the end of the 48 weeks.Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and 52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the past. All of the patients started treatment with the oral solution, but adolescents taking the full adult dose could switch to the capsules after four weeks. The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients' blood.In all three studies, the patients also took ritonavir and a combination of other HIV-medicines that were chosen as they had the best chances of reducing the levels of HIV in their blood.

What benefit has Aptivus shown during the studies?

Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicines in patients with few remaining options for successful HIV treatment. In the two adult studies taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment, compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737). On average, it took 113 days for treatment to stop working in adults taking Aptivus. This was compared with an average of zero days in those taking the comparator, meaning that most of the patients taking the comparator did not respond to their treatment at all.In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and 50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads below 400 copies/ml after 48 weeks.

What is the risk associated with Aptivus?

In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick). Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults. For the full list of all side effects reported with Aptivus, see the package leaflet.Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with kidney or liver impairment. Aptivus with ritonavir must not be used in patients with moderate or severe problems with their liver or who are taking any of the following medicines:• rifampicin (used to treat tuberculosis);• St John's wort (a herbal preparation used to treat depression);• medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood. See the package leaflet for the full list of these medicines.

Why has Aptivus been approved?

The CHMP noted that the studies supported the use of Aptivus capsules in adults. Although theCommittee had some concerns over how the study in children and adolescents was designed, the Committee noted that its results supported the use of the capsules in adolescents and the oral solution in children between the ages of two and 12 years. Therefore, the CHMP decided that the benefits of Aptivus capsules are greater than their risks for the treatment of adults and adolescents 12 years of age or older. The Committee also decided that the benefits of Aptivus oral solution are greater than its risks for children from two to 12 years of age. However, the available information does not support the use of the oral solution in patients aged 12 years or above.The Committee recommended that Aptivus be given marketing authorisation. However, it concluded that the medicine should only be considered for use as 'last line' therapy, when no other protease inhibitors are predicted to work.

What measures are being taken to ensure the safe and effective use of Aptivus?

A risk management plan has been developed to ensure that Aptivus is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aptivus, including the appropriate precautions to be followed by healthcare professionals and patients.


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Aquipta


What is Aquipta and what is it used for?

Aquipta is a medicine used to prevent migraines in adults who have migraines at least 4 days a month.Aquipta contains the active substance atogepant.

How is Aquipta used?

Aquipta is available as tablets to be taken by mouth once a day. It can only be obtained with a prescription.For more information about using Aquipta, see the package leaflet or contact your doctor or pharmacist.

How does Aquipta work?

The exact way that Aquipta works is not fully understood. The active substance in Aquipta, atogepant, attaches to receptors (targets) for proteins called CGRP and amylin-1. These proteins are involved in the development of migraine. By attaching to these receptors, the medicine prevents CGRP and amylin-1 from binding to them. This helps prevent migraines from occurring.

What benefits of Aquipta have been shown in studies?

Aquipta was shown to reduce the number of days patients have migraines in two main studies.In one study involving 882 patients who experienced at least 4 migraines a month, treatment with Aquipta for 12 weeks reduced migraines from around 8 days a month to around 3 to 4 days a month, compared with around 5 days for patients taking placebo (a dummy treatment).In another study involving 760 patients who experienced at least 15 headache days a month with 8 out of these being migraine days, treatment with Aquipta for 12 weeks reduced migraines from around 19 days a month to around 12 days a month, compared with 14 days for patients taking placebo.

What are the risks associated with Aquipta?

For the full list of side effects and restrictions with Aquipta, see the package leaflet.The most common side effects with Aquipta (which may affect up to 1 in 10 people) include nausea (feeling sick), constipation, tiredness, somnolence (sleepiness), decreased appetite and decreased weight.

Why is Aquipta authorised in the EU?

Aquipta can reduce the number of days patients have migraines. Most of the side effects are mild or moderate in severity. Following concerns about a possible link to liver injury, an in-depth safety analysis provided reassurance about the medicine's liver safety profile. The European Medicines Agency therefore decided that Aquipta's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aquipta?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aquipta have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aquipta are continuously monitored. Suspected side effects reported with Aquipta are carefully evaluated and any necessary action taken to protect patients.


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Aranesp


What is Aranesp and what it is used for?

Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. It is used in two groups of patients:• adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly);• adults who are receiving chemotherapy for non-myeloid cancer (cancer not originating in the bone marrow).Aranesp contains the active substance darbepoetin alfa.

How is Aranesp used?

Aranesp can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating the types of anaemia mentioned above.Aranesp is available in a vial, a pre-filled syringe or a pre-filled pen. It is provided in various strengths.For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin. It must be injected under the skin in patients receiving chemotherapy. The dose and frequency of injection depend on why Aranesp is being used, and are adjusted, according to the patient's response, to obtain haemoglobin levels that remain within the recommended range (between 10 and 12 grams per decilitre). Haemoglobin is the protein in red blood cells that carries oxygen around the body. The lowest dose that provides adequate control of symptoms should be used.Aranesp can be injected by the patient or their carer if they have been trained. For more information about using Aranesp, see the package leaflet or contact your doctor or pharmacist.

How does Aranesp work?

In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of a hormone called erythropoietin, or by the body not responding well enough to erythropoietin. The active substance in Aranesp, darbepoetin alfa works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow. It is very slightly different in itsstructure to the natural hormone. Because of the slight changes to the structure, darbepoetin alfa remains in the body for longer than natural erythropoietin.

What benefits of Aranesp have been shown in studies?

Aranesp has been shown to be effective in the treatment of chronic renal failure in four studies involving over 1,200 patients. Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels and at keeping these levels maintained, whether given as an injection into a vein or under the skin.Aranesp has also been studied in 124 children with chronic renal failure to check that it is absorbed in the same way as in adults.In two studies involving 669 patients receiving chemotherapy, Aranesp was more effective than placebo (a dummy treatment) and fewer patients needed a blood transfusion.

What are the risks associated with Aranesp?

In kidney failure patients, the most common side effects with Aranesp (which may affect more than 1 in 10 people) are hypersensitivity (allergy) and hypertension (high blood pressure) while in cancer patients the most common are hypersensitivity and oedema (fluid retention).Aranesp must not be used in patients who have poorly controlled high blood pressure. For the full list of side effects and restrictions, see the package leaflet

Why is Aranesp authorised in the EU?

The European Medicines Agency decided that Aranesp's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aranesp?

The company that markets Aranesp will provide educational packs for patients and healthcare professionals including information on how to self-inject the medicine, a training checklist and a demonstration device.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aranesp have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aranesp are continuously monitored. Side effects reported with Aranesp are carefully evaluated and any necessary action taken to protect patients.


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Arava


What is Arava?

Arava is a medicine that contains the active substance leflunomide. It is available as tablets (10, 20 and 100 mg).

What is Arava used for?

Arava is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).The medicine can only be obtained with a prescription.

How is Arava used?

Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Arava, and regularly during treatment.Arava treatment usually starts with a 'loading dose' of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up to six months.

How does Arava work?

The active substance in Arava, leflunomide, is an immunosuppressant. It reduces inflammation by reducing the production of immune cells called 'lymphocytes', which are responsible for inflammation. Leflunomide does this by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.

How has Arava been studied?

In rheumatoid arthritis, Arava has been studied in four main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis). Two of the studies lasted six months, and two lasted a year. The two longer studies were then extended, with patients remaining on the medicines for at least one more year.In psoriatic arthritis, Arava has been compared with placebo in 186 patients over six months.In all of the studies, the main measure of effectiveness was the number of patients who responded to treatment, as defined by disease-specific criteria (American College of Rheumatology response rates for rheumatoid arthritis, and the Psoriatic Arthritis treatment Response Criteria for psoriatic arthritis).

What benefit has Arava shown during the studies?

In rheumatoid arthritis, Arava was more effective than placebo and as effective as sulphasalazine. Between 49 and 55% of the patients taking Arava responded to treatment, compared with 26 to 28% of those taking placebo, and 54% of those taking sulphasalazine. These results were maintained in the extension studies. Over the first year of treatment, Arava was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B). Arava was not as effective as methotrexate in the extension study.In psoriatic arthritis, Arava was more effective than placebo, with 59% of the patients taking Arava responding to treatment, compared with 30% of those taking placebo.

What is the risk associated with Arava?

The most common side effects with Arava (seen in between 1 and 10 patients in 100) are leucopenia (low white blood cell counts), mild allergic reactions, increased creatine phosphokinase levels (a marker of muscle damage), paraesthesia (abnormal sensations like pins and needles), peripheral neuropathy (nerve damage in hands and feet), headache, dizziness, mild increases in blood pressure, diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal pain (stomach ache), increased liver enzyme levels, hair loss, eczema, rash, pruritus (itching), dry skin, tenosynovitis (inflammation of the sheath surrounding the tendons), loss of appetite, weight loss and asthenia (weakness). For the full list of all side effects reported with Arava, see the package leaflet.Arava must not be used in people who may be hypersensitive (allergic) to leflunomide, to teriflunomide (a breakdown product of leflunomide) or to any of the other ingredients. Arava must not be used in patients with:• liver disease;• severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);• poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;• serious infections;• moderate to severely impaired kidney function;• severe hypoproteinaemia (low blood protein levels).Arava must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception, or during breastfeeding.Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine. They also need to take special care when switching a patient to Arava, or when switching a patient who is receiving Arava to another treatment.

Why has Arava been approved?

The CHMP decided that Arava's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Arava?

A risk management plan has been developed to ensure that Arava is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Arava, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that markets Arava will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Arava and the monitoring that should be carried out in patients.


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Arexvy


What is Arexvy and what is it used for?

Arexvy is a vaccine for adults 60 years of age and older to protect them againstlower respiratory tract disease (LRTD; diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV).Arexvy contains a version of a protein found on the surface of the virus called RSVPreF3.

How is Arexvy used?

The recommended dose is one single injection into a muscle.The vaccine can only be obtained with a prescription and should be used according to official recommendations issued at national level by public health bodies.For more information about using Arexvy, see the package leaflet or contact your doctor or pharmacist.

How does Arexvy work?

Arexvy works by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Arexvy contains a protein from the surface of the RSV virus. When a person is given the vaccine, the immune system treats the virus proteins as 'foreign' and makes defences against them. If, later on, the vaccinated person comes into contact with the virus, the immune system will recognise the virus proteins and be prepared to attack it. This will help to protect against LRTD caused by the virus.

What benefits of Arexvy have been shown in studies?

In a study in over 25,000 adults aged 60 years and above, people who received Arexvy had an 83% reduction in their risk of getting LRTD caused by RSV compared with those who had a dummy injection.In the group who received Arexvy, 7 out of 12,466 vaccinated people got LRTD, while in the group who received dummy injections, 40 out of 12,494 people got the disease.

What are the risks associated with Arexvy?

For the full list of side effects and restrictions with Arexvy, see the package leaflet.The most common side effects with Arexvy (which may affect more than 1 in 10 people) include injection site pain, tiredness, muscle pain, headache and joint pain. These side effects are usually mild or moderate in intensity and resolve within a few days after vaccination.

Why is Arexvy authorised in the EU?

At the time of authorisation of Arexvy, there was no vaccine to prevent RSV and no treatment, other than supportive care, for older adults. The main study showed that Arexvy is effective in preventing RSV-confirmed LRTD in this patient group. By preventing RSV-confirmed LRTD, the vaccine is also expected to reduce the risk of severe RSV disease.There are no serious safety concerns and the European Medicines Agency therefore decided that Arexvy's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Arexvy?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arexvy have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Arexvy are continuously monitored. Suspected side effects reported with Arexvy are carefully evaluated and any necessary action taken to protect patients.


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Arikayce Liposomal


What is Arikayce liposomal and what is it used for?

Arikayce liposomal is an antibiotic for treating adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water. It is used in patients with limited treatment options who do not have cystic fibrosis.Lung infection caused by MAC is rare, and Arikayce liposomal was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 April 2014. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations eu3141259.Arikayce liposomal contains the active substance amikacin.

How is Arikayce liposomal used?

The patient inhales Arikayce liposomal through the mouth once a day using a nebuliser (a machine for turning the medicine into a mist that the patient can breathe in). If tests show that the infection has cleared, the patient should continue using Arikayce liposomal for a further 12 months; however, if the infection shows no sign of clearing 6 months after starting treatment, the medicine should be stopped.Arikayce liposomal is used together with other antibiotics. It can only be obtained with a prescription, and treatment should be started and managed by a doctor experienced in treating MAC lung infection.Prescribers should consider official guidance on the use of antibiotics.For more information about using Arikayce liposomal, see the package leaflet or contact your doctor or pharmacist.

How does Arikayce liposomal work?

Amikacin is an antibiotic that belongs to the group 'aminoglycosides'. It works by disrupting the production of proteins that bacteria need to build their cell walls, thereby damaging the bacteria and eventually killing them. In this medicine, amikacin is contained in tiny fat particles known as liposomes, which allows the medicine to remain in the lung for longer.

What benefits of Arikayce liposomal have been shown in studies?

A main study in 336 patients showed that Arikayce liposomal is effective at clearing lung infections caused by MAC. After 6 months of treatment, 29% of patients on standard care who used Arikayce liposomal tested negative for the infection, compared with 9% of patients on standard care alone. In addition, 3 months after stopping treatment, 55% of patients whose infections cleared with Arikayce liposomal continued to test negative. No patient who received standard care tested negative 3 months after stopping treatment.

What are the risks associated with Arikayce liposomal?

The most common side effects with Arikayce liposomal affect the lungs and airways: dysphonia (changes to the voice), cough, dyspnoea (difficulty breathing) and haemoptysis (coughing up blood) may affect more than 1 person in 10.Other common side effects include pain in the mouth or throat, tiredness, diarrhoea, worsening of bronchiectasis (weakened, scarred airways and build-up of mucus) due to infection, nausea (feeling sick) and bronchospasm.Arikayce liposomal must not be used in patients who are hypersensitive (allergic) to soya, to any aminoglycoside antibiotic or to any ingredient of this medicine. It must also not be used together with another aminoglycoside or in patients with severely impaired kidneys.For the full list of side effects of Arikayce liposomal, see the package leaflet.

Why is Arikayce liposomal authorised in the EU?

The main study showed that Arikayce liposomal can clear MAC lung infection in some patients. Although the effect of Arikayce liposomal is modest, the medicine could benefit patients who have few treatment options. In terms of its safety, Arikayce liposomal can cause significant side effects, particularly during the first months of treatment. The Agency therefore recommended restricting the medicine to patients with limited treatment options.The Agency concluded that the benefits of Arikayce liposomal outweigh its risks and that it can be authorised in the EU.

What measures are being taken to ensure the safe and effective use of Arikayce liposomal?

The company will provide patients taking the medicine with an alert card to inform them of the risk of allergic alveolitis (inflammation in the lungs due to an allergy).Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arikayce liposomal have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Arikayce liposomal are continuously monitored. Side effects reported with Arikayce liposomal are carefully evaluated and any necessary action taken to protect patients.


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Aripiprazole Accord


What is Aripiprazole Accord and what is it used for?

Aripiprazole Accord is a medicine used in patients with the following mental illnesses:• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions(false beliefs). Aripiprazole Accord is used in patients aged 15 years or over;• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood. They may also have episodes of depression. Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past. Aripiprazole Accord is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.Aripiprazole Accord contains the active substance aripiprazole and is a 'generic medicine'. This means that Aripiprazole Accord is similar to a 'reference medicine' already authorised in the European Union (EU) called Abilify. For more information on generic medicines, see the question-and-answer document here.

How is Aripiprazole Accord used?

Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a'maintenance' dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg once a day, either on its own or in combination with other medicines. To prevent manic episodes in adults, the same dose should be continued.For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day(using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks.The dose should be adjusted in patients who are taking other medicines that affect the wayAripiprazole Accord is broken down in the body. For further information, see the Summary of Product Characteristics (also part of the EPAR).

How does Aripiprazole Accord work?

The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly by being a 'partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.

How has Aripiprazole Accord been studied?

Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Aripiprazole Accord?

Because Aripiprazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Aripiprazole Accord approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify. Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk. The Committee recommended that Aripiprazole Accord be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?

A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.


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Aripiprazole Mylan Pharma


What is Aripiprazole Mylan Pharma and what is it used for?

Aripiprazole Mylan Pharma is used in patients with the following mental illnesses:• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions(false beliefs). Aripiprazole Mylan Pharma is used in patients aged 15 years or over;• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood. They may also have episodes of depression. Aripiprazole Mylan Pharma is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past. Aripiprazole Mylan Pharma is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.Aripiprazole Mylan Pharma contains the active substance aripiprazole and is a 'generic medicine'. This means that Aripiprazole Mylan Pharma is similar to a 'reference medicine' already authorised in the European Union (EU) called Abilify. For more information on generic medicines, see the question-andanswer document here.1 Previously known as Aripiprazole Pharmathen.

How is Aripiprazole Mylan Pharma used?

Aripiprazole Mylan Pharma is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a 'maintenance' dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines. To prevent manic episodes in adults, the same dose should be continued.For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day(using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks.The dose should be adjusted in patients who are taking other medicines that affect the wayAripiprazole Mylan Pharma is broken down in the body. For further information, see the Summary of Product Characteristics (also part of the EPAR).

How does Aripiprazole Mylan Pharma work?

The active substance in Aripiprazole Mylan Pharma, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly by being a 'partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.

How has Aripiprazole Mylan Pharma been studied?

Because Aripiprazole Mylan Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Aripiprazole Mylan Pharma?

Because Aripiprazole Mylan Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Aripiprazole Mylan Pharma approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Abilify. Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk. The Committee recommended that Aripiprazole Mylan Pharma be approved for use in the EU.Aripiprazole Mylan Pharma0F

What measures are being taken to ensure the safe and effective use of Aripiprazole Mylan Pharma?

A risk management plan has been developed to ensure that Aripiprazole Mylan Pharma is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Mylan Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that markets Aripiprazole Mylan Pharma will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.


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Aripiprazole Sandoz


What is Aripiprazole Sandoz and what is it used for?

Aripiprazole Sandoz is used in patients with the following mental illnesses:• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions(false beliefs). Aripiprazole Sandoz is used in patients aged 15 years or over;• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood. They may also have episodes of depression. Aripiprazole Sandoz is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults whose illness has improved with the medicine in the past.Aripiprazole Sandoz is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.Aripiprazole Sandoz contains the active substance aripiprazole and is a 'generic' and a 'hybrid' medicine. This means that it is similar to a 'reference medicine', but it contains aripiprazole at a new strength in addition to existing strengths: while the reference medicine, Abilify, is available as 5, 10, 15 and 30 mg, Aripiprazole Sandoz is also available as 20 mg tablets. For more information on generic and hybrid medicines, see the question-and-answer document here.

How is Aripiprazole Sandoz used?

Aripiprazole Sandoz is available as tablets and can only be obtained with a prescription.For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a 'maintenance' dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines. To prevent manic episodes in adults, the same dose should be continued.For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day(using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks.The dose should be adjusted in patients who are taking other medicines that affect the wayAripiprazole Sandoz is broken down in the body. For further information, see the summary of product characteristics (also part of the EPAR).

How does Aripiprazole Sandoz work?

The active substance in Aripiprazole Sandoz, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several different receptors on nerve cells in the brain. This disrupts signals transmitted between brain nerve cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly by being a 'partial agonist' at the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. In this way, aripiprazole helps to change the activity of the nerve cells which are thought to give rise to psychotic or manic symptoms and preventing them from returning.

How has Aripiprazole Sandoz been studied?

The company provided data from the published literature on aripiprazole.The company carried out 'bioequivalence' studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Aripiprazole Sandoz?

Because Aripiprazole Sandoz is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Aripiprazole Sandoz approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify. Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk. The Committee recommended that Aripiprazole Sandoz be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Aripiprazole Sandoz?

A risk management plan has been developed to ensure that Aripiprazole Sandoz is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.In addition, when used for patients aged 13 years or older with moderate to severe manic episodes in bipolar I disorder, the company that markets Aripiprazole Sandoz will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in these patients.


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Aripiprazole Zentiva


What is Aripiprazole Zentiva and what is it used for?

Aripiprazole Zentiva is used in patients with the following mental illnesses:• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions(false beliefs). Aripiprazole Zentiva is used in patients aged 15 years or over;• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood. They may also have episodes of depression. Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past. Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.Aripiprazole Zentiva contains the active substance aripiprazole and is a 'generic medicine'. This means that Aripiprazole Zentiva is similar to a 'reference medicine' already authorised in the European Union (EU) called Abilify. For more information on generic medicines, see the question-and-answer document here.

How is Aripiprazole Zentiva used?

Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg). It can only be obtained with a prescription.For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a 'maintenance' dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines. To prevent manic episodes in adults, the same dose should be continued.For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day(using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks.The dose should be adjusted in patients who are taking other medicines that affect the wayAripiprazole Zentiva is broken down in the body. For further information, see the Summary of Product Characteristics (also part of the EPAR).The orodispersible tablets can be used in patients who have difficulty swallowing tablets.

How does Aripiprazole Zentiva work?

The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly by being a 'partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.

How has Aripiprazole Zentiva been studied?

Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Aripiprazole Zentiva?

Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Aripiprazole Zentiva approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to bebioequivalent to Abilify. Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk. The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Aripiprazole Zentiva?

A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.


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Arixtra


What is Arixtra?

Arixtra is a solution for injection in a prefilled syringe. Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).

What is Arixtra used for?

Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems due to the formation of blood clots in the veins) in adults (aged 18 years or over) who are having major surgery to their legs, such as a hip or knee surgery. It can also be used in adults at high risk (because of their age or disease) when they are having abdominal surgery or are forced to stay in bed because of an acute illness.Arixtra (1.5 and 2.5 mg strengths) is also used to treat adults who have blood clots in the superficial veins of the legs (superficial venous thrombosis) but not in their deep veins (deep vein thrombosis, DVT).At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat DVT or pulmonary embolism (PE, clot in a blood vessel supplying the lungs).The 2.5 mg strength is also used to treat adults with unstable angina (a type of chest pain that changes in severity due to reduced blood flow to the heart) or who are having a myocardial infarction (heart attack) with or without 'ST segment elevation' (an abnormal reading on the electrocardiogram or ECG).The medicine can only be obtained with a prescription.

How is Arixtra used?

In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin). For patients having surgery, the first dose should be given six hours after the end of the operation. Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery. For patients who have kidney problems, Arixtra may not be suitable, or the 1.5-mg dose may be used.In the treatment of superficial vein thrombosis, the recommended dose is 2.5 mg once a day by subcutaneous injection. Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days.In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days. The dose may be adjusted depending on body weight.For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein) through an existing line or as an infusion (drip) in patients with ST segment elevation. Treatment should be started as soon as possible after diagnosis and continued for up to eight days or until the patient is discharged from hospital. Arixtra is not recommended in patients who are about to undergo certain types of operations to unblock the heart's blood vessels.For more information, see the summary of product characteristics (also part of the EPAR).

How does Arixtra work?

Blood clotting can be a problem when blood flow is disturbed in any way. Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting). The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, factor Xa. When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed. By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced. By reducing blood clots, Arixtra can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.

How has Arixtra been studied?

Arixtra has been studied for the prevention of and in the treatment of VTE. In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients). It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).In the treatment of VTE such as DVT and PE, Arixtra was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients). In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).In the treatment of superficial vein thrombosis, Arixtra was compared with placebo in one study of 3,000 patients with superficial vein thrombosis of the legs, without DVT. The main measure of effectiveness of this study was the overall occurrence of VTE or death.Arixtra has also been studied in two main studies of patients with unstable angina or myocardial infarction. The first compared the effects of Arixtra with those of enoxaparin in over 20,000 patientsArixtrawith unstable angina or myocardial infarction without ST segment elevation, and the second compared Arixtra with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation. The main measure of effectiveness was the proportion of patients who died or had an 'ischaemic event' (restriction of blood supply to an organ, including the heart).

What benefit has Arixtra shown during the studies?

Arixtra was at least as effective as the comparators in all of the studies that looked at the prevention of VTE and treatment of DVT and PE. The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.Arixtra was more effective than placebo in reducing the overall occurrence of VTE or death in patients with superficial vein thrombosis. While there was one VTE or death for every 100 patients taking Arixtra, there were six for every hundred taking placebo.Arixtra was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days. In the study of myocardial infarction with ST segment elevation, Arixtra reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care. However, these results were insufficient to show whether Arixtra was more effective than unfractionated heparin or not.

What is the risk associated with Arixtra?

As with other anticoagulant medicines, the most common side effect of Arixtra is bleeding. For the full list of all side effects reported with Arixtra, see the package leaflet.Arixtra should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems. For the full list of restrictions, see the package leaflet.

Why has Arixtra been approved?

The CHMP decided that Arixtra's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Armisarte


What is Armisarte and what is it used for?

Armisarte is a cancer medicine used to treat two types of lung cancer:• malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;• advanced non-small-cell lung cancer of the kind known as 'non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment. It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.Armisarte is a 'hybrid medicine'. This means that Armisarte is similar to a 'reference medicine' already authorised in the European Union (EU) called Alimta, but it is available in a different form. While Alimta is available as a powder to be made up into a solution for infusion (drip) into a vein, Armisarte is available as a concentrated liquid to be made up into a solution for infusion.Armisarte contains the active substance pemetrexed.1 1Previously known as Pemetrexed Actavis.

How is Armisarte used?

Armisarte is available as a concentrate for solution for infusion into a vein. The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of cancer medicines.The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight). It is given once every three weeks as an infusion lasting 10 minutes. To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Armisarte. When Armisarte is given with cisplatin, an 'anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects. For more information, see the summary of product characteristics (also part of the EPAR).

How does Armisarte work?

The active substance in Armisarte, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group 'antimetabolites'. In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing 'nucleotides' (the building blocks of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying. The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This results in the division of cancer cells being reduced, while normal cells are only slightly affected.

How has Armisarte been studied?

The company provided data from the published literature on pemetrexed. No additional studies were needed as Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.

What are the benefits and risks of Armisarte?

Because Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Armisarte approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Armisarte has been shown to be comparable to Alimta. Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk. The Committee recommended that Armisarte be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Armisarte?

A risk management plan has been developed to ensure that Armisarte is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Armisarte, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.


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Arsenic Trioxide Accord


What is Arsenic trioxide Accord and what is it used for?

Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic 'translocation' (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).Patients with APL are normally treated with retinoids (substances derived from vitamin A).Arsenic trioxide Accord is used in:• Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.• Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.Arsenic trioxide Accord contains the active substance arsenic trioxide and is a 'generic medicine'. This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Trisenox. For more information on generic medicines, see the question-and-answer document here.

How is Arsenic trioxide Accord used?

Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias. It is given as an infusion (drip) into a vein. The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.The recommended dose of Arsenic trioxide Accord depends on the patient's weight. Treatment is divided into 2 phases: induction and consolidation.During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells). If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.SendDuring the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist.

How does Arsenic trioxide Accord work?

The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia. The way it works in this disease is not completely understood. It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.

How has Arsenic trioxide Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord. There was no need for 'bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Arsenic trioxide Accord?

Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Arsenic trioxide Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox. Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored. Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.


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Arsenic Trioxide Medac


What is Arsenic trioxide medac and what is it used for?

Arsenic trioxide medac is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL).APL is a rare form of leukaemia (cancer of the white blood cells) caused by a genetic 'translocation' (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A).Arsenic trioxide medac is used in:• patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA);• patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.Arsenic trioxide medac is a 'generic medicine'. This means that Arsenic trioxide medac contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Trisenox. For more information on generic medicines, see the question-and-answer document here.Arsenic trioxide medac contains the active substance arsenic trioxide.

How is Arsenic trioxide medac used?

Arsenic trioxide medac can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias. The medicine is given by infusion (drip) into a vein. The infusion should last one to two hours, but the doctor may have to slow it down if the patient has certain side effects.The recommended dose of Arsenic trioxide medac depends on the patient's body weight. The treatment is divided into 2 phases: induction and consolidation.During the induction phase, Arsenic trioxide medac is given every day until there are signs that the treatment is working (when the bone marrow no longer contains any leukaemia cells). If this does notSendhappen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.During the consolidation phase, Arsenic trioxide medac is given once a day for five days, followed by a two-day break, repeated for four or five weeks. The number of times these cycles are repeated depends on whether patients have received previous treatment or not.For more information about using Arsenic trioxide medac, see the package leaflet or contact your doctor or pharmacist.

How does Arsenic trioxide medac work?

The active substance in Arsenic trioxide medac, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia. The way it works in this disease is not completely understood. It is thought to prevent the production of DNA (genetic material), which is necessary for leukaemia cells to grow.

How has Arsenic trioxide medac been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide medac.As for every medicine, the company provided studies on the quality of Arsenic trioxide medac. There was no need for 'bioequivalence' studies to investigate whether Arsenic trioxide medac is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Arsenic trioxide medac is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Arsenic trioxide medac?

Because Arsenic trioxide medac is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Arsenic trioxide medac authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide medac has been shown to be comparable to Trisenox. Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide medac outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Arsenic trioxide medac?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide medac have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Arsenic trioxide medac are continuously monitored. Side effects reported with Arsenic trioxide medac are carefully evaluated and any necessary action taken to protect patients.


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Arsenic Trioxide Mylan


What is Arsenic trioxide Mylan and what is it used for?

Arsenic trioxide Mylan is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic 'translocation' (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).Patients with APL are normally treated with retinoids (substances derived from vitamin A).Arsenic trioxide Mylan is used in:• patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA);• patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.Arsenic trioxide Mylan is a 'generic medicine'. This means that Arsenic trioxide Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Trisenox. For more information on generic medicines, see the question-and-answer document here.Arsenic trioxide Mylan contains the active substance arsenic trioxide.

How is Arsenic trioxide Mylan used?

Arsenic trioxide Mylan can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias. It is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The infusion should last one to two hours, but it may last longer if the patient has certain side effects.The recommended dose of Arsenic trioxide Mylan depends on the body weight of the patient. The treatment is divided into 2 phases: induction and consolidation.During the induction phase, Arsenic trioxide Mylan is given every day until there are signs that the treatment is working (when the bone marrow no longer contains any leukaemia cells). If this does notSendhappen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.During the consolidation phase, Arsenic trioxide Mylan is given once a day for five days, followed by a two-day break, repeated for four or five weeks. The number of times these cycles are repeated depends on whether patients have received previous treatment or not.For more information about using Arsenic trioxide Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Arsenic trioxide Mylan work?

The active substance in Arsenic trioxide Mylan, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia. The way it works in this disease is not completely understood. It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.

How has Arsenic trioxide Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Mylan.As for every medicine, the company provided studies on the quality of Arsenic trioxide Mylan. There was no need for 'bioequivalence' studies to investigate whether Arsenic trioxide Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Arsenic trioxide Mylan is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Arsenic trioxide Mylan?

Because Arsenic trioxide Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Arsenic trioxide Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxideMylan has been shown to be comparable to Trisenox. Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Arsenic trioxide Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Mylan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Arsenic trioxide Mylan are continuously monitored. Side effects reported with Arsenic trioxide Mylan are carefully evaluated and any necessary action taken to protect patients.


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Artesunate Amivas


What is Artesunate Amivas and what is it used for?

Artesunate Amivas is a malaria medicine used as initial treatment of severe malaria in adults and children. Malaria is an infection caused by a parasite known as Plasmodium. 'Severe' malaria means the disease involves potentially life-threatening symptoms.Malaria is rare in the EU, and Artesunate Amivas was designated an 'orphan medicine' (a medicine used in rare diseases) on 28 February 2020. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3202251.Artesunate Amivas contains the active substance artesunate.

How is Artesunate Amivas used?

Artesunate Amivas can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antimalarial agents. The medicine should only be used after consultation with a doctor experienced in the management of malaria.The medicine is available as a powder and solvent to be made up into a solution for injection into a vein. The recommended dose is based on the patient's weight and should be given every 12 hours during the first 24 hours (0, 12 and 24 hours). Treatment with Artesunate Amivas should continue with one injection every 24 hours until the patient is able to take appropriate malaria treatment by mouth.For more information about using Artesunate Amivas, see the package leaflet or contact your doctor or pharmacist.

How does Artesunate Amivas work?

The active substance in Artesunate Amivas, artesunate, is a derivative of the naturally occurring substance artemisinin. Its exact mode of action is not fully understood, but once it has entered blood cells infected by the malaria parasite, the medicine is thought to form toxic substances called 'free radicals' that kill the parasite.

What benefits of Artesunate Amivas have been shown in studies?

Two main studies showed that initial treatment with injectable artesunate was more effective than that with another malaria medicine, quinine, in reducing the risk of death in hospitalised patients with severe malaria.The first study involved 1,461 adults and children. Patients received injectable treatment until they were able to receive treatment by mouth, either with Artesunate Amivas or with quinine. The results showed that 107 out of 730 (14.7%) patients who received initial treatment with Artesunate Amivas died in hospital compared with 164 out of 731 (22.4%) of those who received initial treatment with quinine.In the second study, which involved 5,425 children under 15 years of age hospitalised with malaria, 230 out of 2712 (8.5%) patients who received Artesunate Amivas by injection followed by treatment with the malaria medicine artemether-lumefantrine died in hospital compared with 297 out of 2713 (10.9%) of those who received quinine by injection followed by artemether-lumefantrine.

What are the risks associated with Artesunate Amivas?

The most common side effects with Artesunate Amivas (which may affect more than 1 in 10 people) are anaemia (low levels of red blood cells), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and post-artesunate delayed haemolysis (breakdown of red blood cells at least seven days after starting artesunate treatment, which may cause anaemia).For the full list of side effects and restrictions of Artesunate Amivas, see the package leaflet.

Why is Artesunate Amivas authorised in the EU?

Two studies have shown that initial treatment with Artesunate Amivas given by injection improves inhospital survival in adults and children with severe malaria compared with quinine given by injection. The safety profile of Artesunate Amivas when given by injection into a vein was considered acceptable. The European Medicines Agency therefore decided that Artesunate Amivas's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Artesunate Amivas?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Artesunate Amivas have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Artesunate Amivas are continuously monitored. Suspected side effects reported with Artesunate Amivas are carefully evaluated and any necessary action taken to protect patients.


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Aspaveli


What is Aspaveli and what is it used for?

Aspaveli is a medicine to treat adults with paroxysmal nocturnal haemoglobinuria (PNH), a condition in which there is excessive breakdown of red blood cells (haemolysis), leading to large amounts of haemoglobin (the protein in red blood cells that carries oxygen around the body) being released into the urine. Aspaveli is used in patients who continue to have anaemia (low levels of red blood cells) despite treatment with a type of medicine called a C5 inhibitor for at least 3 months.Paroxysmal nocturnal haemoglobinuria is rare, and Aspaveli was designated an 'orphan medicine' (a medicine used in rare diseases) on 22 May 2017. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3171873.Aspaveli contains the active substance pegcetacoplan.

How is Aspaveli used?

The medicine can only be obtained with a prescription. Treatment should be started under the supervision of a healthcare professional experienced in the management of blood-related disorders.Aspaveli is given as an infusion (drip) under the skin in the belly, thigh or upper arms. It is given twice a week (on day 1 and 4).Patients should continue to received their C5 inhibitor for 4 weeks after starting Aspaveli before stopping the C5 inhibitor..Patients can give themselves the drip once they have been trained to do so.For more information about using Aspaveli, see the package leaflet or contact your doctor or pharmacist.

How does Aspaveli work?

Aspaveli is made of two synthetic peptides (short chains of amino acids) linked together, which target and attach to the C3 complement protein, which is a part of the body's defence system called the 'complement system'.In patients with PNH, the complement proteins are over-active and damage the patients' own cells. By blocking the C3 complement protein, Aspaveli prevents complement proteins from damaging cells, thereby helping to relieve the symptoms of this disease.

What benefits of Aspaveli have been shown in studies?

Aspaveli was shown to be effective at preventing breakdown of haemoglobin and increasing its blood levels in patients with PNH who had been treated with eculizumab for at least 3 months but were still anaemic.The main study was conducted in 80 patients with PNH currently being treated with eculizumab, a C5 inhibitor, but who continued to be anaemic (haemoglobin level <10.5 g/dL) despite this treatment. Patients were either switched to Aspaveli or continued their eculizumab treatment. After 16 weeks, the haemoglobin levels in patients receiving Aspaveli increased on average by 2.37 g/dl while it decreased by 1.47 g/dl on average in patients who were still treated with eculizumab. During this period, 6 of 41 people given Aspaveli needed a blood transfusion, compared with 33 of 39 treated with eculizumab.

What are the risks associated with Aspaveli?

The most common side effects with Aspaveli (which may affect more than 1 in 10 people) are injection site reactions (reddening of the skin, itching, swelling and site pain), upper respiratory tract infection, abdominal pain, diarrhoea, headache, tiredness, and fever. The most serious side effects are haemolysis (breakdown of red blood cells) and thrombocytopenia (low levels of blood platelets), which may affect up to 1 in 10 people.Based on its mechanism of action, Aspaveli may increase the risk of infections. Aspaveli must not be used in patients with an ongoing infection caused by certain bacteria known as encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. It must also not be used in patients who are not currently vaccinated against infection by these bacteria. People who get vaccinated must take appropriate antibiotics to reduce the risk of infection for two weeks after vaccination.For the full list of side effects and restrictions, see the package leaflet.

Why is Aspaveli authorised in the EU?

Aspaveli has been shown to be effective at increasing blood haemoglobin levels in patients with PNH who had been treated with eculizumab for at least 3 months but were still anaemic. It also reduced the need for blood transfusions in these patients. In terms of safety, although the data on safety are limited due to the small number of patients included in the main study, the side effects of Aspaveli are considered manageable, considering the risk minimisation measures in place.The European Medicines Agency decided that Aspaveli's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aspaveli?

The company that markets Aspaveli will ensure that distribution of the medicine occurs only after checking that the patient has been vaccinated appropriately. The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if any further vaccination is needed for patients taking Aspaveli. Patients will alsobe given a special card that explains the symptoms of certain types of infection, instructing patients to seek medical care immediately if they experience them.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aspaveli have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aspaveli are continuously monitored. Suspected side effects reported with Aspaveli are carefully evaluated and any necessary action taken to protect patients.


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Atazanavir Krka


What is Atazanavir Krka and what is it used for?

Atazanavir Krka is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS). It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.Doctors should prescribe Atazanavir Krka only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Krka. The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Krka (protease inhibitors) do not work.Atazanavir Krka contains the active substance atazanavir and is a 'generic medicine'. This means that Atazanavir Krka contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Reyataz. For more information on generic medicines, see the question-and-answer document here.

How is Atazanavir Krka used?

Atazanavir Krka is available as capsules (150 mg, 200 mg and 300 mg). It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.For adults, the recommended dose is 300 mg once a day. In younger patients, the dose of Atazanavir Krka depends on body weight. Each dose must be taken with food.Atazanavir Krka is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.For more information about using Atazanavir Krka, see the package leaflet or contact your doctor or pharmacist.

How does Atazanavir Krka work?

The active substance in Atazanavir Krka, atazanavir, is a protease inhibitor. It blocks an enzyme called protease, which is needed for the HIV virus to multiply. Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection. A small dose of another medicine, ritonavir, is normally given at the same time as a 'booster'. Ritonavir slows down the break-down of atazanavir, increasing the levels of atazanavir in the blood. This allows a lower dose of atazanavir to be used for the same antiviral effect. Atazanavir Krka, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Atazanavir Krka does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Atazanavir Krka been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Reyataz, and do not need to be repeated for Atazanavir Krka.As for every medicine, the company provided studies on the quality of Atazanavir Krka. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Atazanavir Krka?

Because Atazanavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Atazanavir Krka authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Atazanavir Krka has been shown to have comparable quality and to be bioequivalent to Reyataz. Therefore, the Agency's view was that, as for Reyataz, the benefit of Atazanavir Krka outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Atazanavir Krka?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Krka have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Atazanavir Krka are continuously monitored. Side effects reported with Atazanavir Krka are carefully evaluated and any necessary action taken to protect patients.


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Atazanavir Mylan


What is Atazanavir Mylan and what is it used for?

Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS). It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.Doctors should prescribe Atazanavir Mylan only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Mylan. The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.Atazanavir Mylan contains the active substance atazanavir.Atazanavir Mylan is a 'generic medicine'. This means that Atazanavir Mylan is similar to a 'reference medicine' already authorised in the European Union (EU) called Reyataz. For more information on generic medicines, see the question-and-answer document here.

How is Atazanavir Mylan used?

Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg). It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.For adults, the recommended dose is 300 mg once a day. In younger patients, the dose of Atazanavir Mylan depends on body weight. Each dose must be taken with food.Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.

How does Atazanavir Mylan work?

The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor. It blocks an enzyme called protease, which is needed for the virus to multiply. Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection. A small dose of another medicine, ritonavir, is normally given at the same time as a 'booster'. Ritonavir slows down the break-down of atazanavir, increasing the levels of atazanavir in the blood. This allows a lower dose of atazanavir to be used for the same antiviral effect. Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Atazanavir Mylan been studied?

Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Atazanavir Mylan?

Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Atazanavir Mylan approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz. Therefore, the CHMP's view was that, as for Reyataz, the benefit outweighs the identified risk. The Committee recommended that Atazanavir Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Mylan have been included in the summary of product characteristics and the package leaflet.


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Atectura Breezhaler


What is Atectura Breezhaler and what is it used for?

Atectura Breezhaler is a medicine that is used to keep the airways open in adults and children aged 12 years and older whose asthma is not adequately controlled with inhaled corticosteroids and inhaled short acting beta-2 agonists. Atectura Breezhaler is used for maintenance (regular) treatment.The medicine contains the active substances indacaterol and mometasone.

How is Atectura Breezhaler used?

Atectura Breezhaler capsules, which contain a powder for inhalation, are to be used only with the inhaler provided with each prescription and must not be swallowed. To receive a dose, the patient places a capsule into the inhaler and breathes in the powder through the mouth.The recommended dose is one capsule, once a day at the same time each day. Patients should not use more than one capsule in a day. The capsules are available in three strengths (125 micrograms / 62.5 micrograms, 125 micrograms / 127.5 micrograms, 125 micrograms / 260 micrograms) and the doctor will decide which strength the patient should use based on the patient's need.The medicine can only be obtained with a prescription.For more information about using Atectura Breezhaler, see the package leaflet or contact your doctor or pharmacist.

How does Atectura Breezhaler work?

The two active substances in Atectura Breezhaler are well known and are present in several medicines used to treat respiratory obstructive diseases, either alone or in combination with other medicines.Indacaterol is a long acting beta-2 adrenergic receptor agonist. It works by attaching to targets called beta-2 receptors in the muscle cells that surround the airways into the lungs. When AtecturaBreezhaler is inhaled, indacaterol reaches the receptors and activates them. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily. Mometasone belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system. By attaching to receptors in various immune cells, it blocks the release of substances involvedSend us a qin the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.

What benefits of Atectura Breezhaler have been shown in studies?

In two main studies involving over 3,000 patients with asthma, Atectura Breezhaler was compared with mometasone alone or a combination of salmeterol and fluticasone (other inhaled medicines used to treat asthma). The main measure of effectiveness was based on changes in patients' forced expiratory volume (FEV1, the maximum volume of air a person can breathe out in one second). FEV1 was measured just before the next dose was due when it was likely to be at its lowest.In the first study, Atectura Breezhaler was more effective than mometasone alone at improving how well the airways work in patients with asthma. The average FEV1 in patients who received Atectura Breezhaler (125 micrograms/62.5 micrograms) was about 180 ml more than with an equivalent dose of mometasone after 12 weeks of treatment.In the second study, medium and high strength Atectura Breezhaler led after 26 weeks to averageFEV1 of about 130 ml to 210 ml more than patients who received equivalent doses of mometasone. The treatment difference between high strength Atectura Breezhaler (125 micrograms/260 micrograms and the combination of salmeterol and fluticasone was about 40 ml in favour of Atectura Breezhaler.The studies also showed an improvement in symptoms such as breathlessness and wheezing.

What are the risks associated with Atectura Breezhaler?

The most common side effects with Atectura Breezhaler (which may affect more than 1 in 10 people) are worsening of asthma and nasopharyngitis (inflammation in the nose and throat). Other common side effects (which may affect up to 1 in 100 people) include upper respiratory tract infection (nose and throat infections) and headache. For the full list of all side effects and restrictions with Atectura Breezhaler, see the package leaflet.

Why is Atectura Breezhaler authorised in the EU?

The European Medicines Agency concluded that Atectura Breezhaler was effective at improving lung function and symptoms in asthma. The Agency also noted that there were no major safety concerns with Atectura Breezhaler, with side effects being manageable and similar to other inhaled medicines of the same class. Therefore, the Agency decided that Atectura Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Atectura Breezhaler?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atectura Breezhaler have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Atectura Breezhaler are continuously monitored. Side effects reported with Atectura Breezhaler are carefully evaluated and any necessary action taken to protect patients.


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Atosiban Sun


What is Atosiban SUN and what is it used for?

Atosiban SUN is a medicine that contains the active substance atosiban. It is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth preterm (prematurely). These signs include:• regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;• dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.In addition, the baby must have a normal heart rate.Atosiban SUN is a 'generic medicine'. This means that Atosiban SUN is similar to a 'reference medicine' already authorised in the European Union (EU) called Tractocile. For more information on generic medicines, see the question-and-answer document here.

How is Atosiban SUN used?

Atosiban SUN can only be obtained with a prescription. Treatment with Atosiban SUN should be carried out by a doctor who has experience in the treatment of pre-term labour.Treatment should be started as soon as possible after diagnosis of pre-term labour. Atosiban SUN is available as a solution for injection and as a concentrate that is made up into a solution for infusion(drip) into a vein. It is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours. If contractions come back, treatment with Atosiban SUN can be repeated up to three more times during the pregnancy.

How does Atosiban SUN work?

The active substance in Atosiban SUN, atosiban, is an antagonist of the natural hormone oxytocin. This means that atosiban blocks the action of oxytocin. Oxytocin is the hormone involved in starting contractions of the womb. By blocking the action of oxytocin, Atosiban SUN prevents contractions and causes the womb to relax, helping to delay birth.

How has Atosiban SUN been studied?

The company provided data from the published literature on atosiban. No additional studies were needed as Atosiban SUN is a generic medicine that is given by infusion or injection and contains the same active substance as the reference medicine, Tractocile.

What are the benefits and risks of Atosiban SUN?

Because Atosiban SUN is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Atosiban SUN approved?

The CHMP concluded that, in accordance with EU requirements, Atosiban SUN has been shown to have comparable quality and to be comparable to Tractocile. Therefore, the CHMP's view was that, as for Tractocile, the benefit outweighs the identified risk. The Committee recommended that Atosiban SUN be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Atosiban SUN?

A risk management plan has been developed to ensure that Atosiban SUN is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atosiban SUN, including the appropriate precautions to be followed by healthcare professionals and patients.


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Atriance


What is Atriance and what is it used for?

Atriance is a cancer medicine used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly. In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland). Atriance is used when the cancer has not responded to, or has stopped responding to, at least two types of chemotherapy.Atriance contains the active substance nelarabine.

How is Atriance used?

Atriance can only be obtained with a prescription and is given by drip into a vein under the supervision of a doctor who has experience in the use of thes type of medicine.The dose and frequency of infusion depend on the patient's age and body surface area (calculated using the patient's height and weight). In adults and adolescents aged 16 years and over, the recommended starting dose is 1,500 mg per square metre of body surface area, given over two hours on days one, three and five, repeated every 21 days. Patients aged under 16 years receive a dose of 650 mg per square metre given over one hour on five consecutive days, repeated every 21 days. This schedule can also be used in patients aged 16 to 21 years. Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system. Treatment may be delayed if other side effects occur.Patients receiving Atriance should be monitored regularly for changes in blood cell counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).For more information about using Atriance, see the package leaflet or contact your doctor or pharmacist.

How does Atriance work?

The active substance in Atriance, nelarabine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells. It belongs to the group of cancer medicines called 'antimetabolites'.Nelarabine is converted within cells into an analogue of guanine, one of the fundamental chemicals that make up DNA. In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases. This stops the production of DNA and thus slows down the growth and multiplication of cells. Because the guanine analogue accumulates in Tcells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.

What benefits of Atriance have been shown in studies?

Atriance was shown to be effective in two main studies involving patients with T-ALL and T-LBL whose cancer had stopped responding to one or more previous cancer treatments. In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine. The first study involved 70 children and young adults below 21 years of age. Of those whose cancer had not responded to two or more previous treatments (39) five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts. In the second study, involving a total of 40 adults and adolescents above the age of 16. Of those whose cancer had not responded (28) five (18%) had a complete response to treatment. In both studies, compared to patients who had a complete response more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.

What are the risks associated with Atriance?

The most common side effects with Atriance in adults (which may affect more than 1 in 10 people) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoaesthesia (a reduced sense of touch), paraesthesia (unusual sensations like pins and needles), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, tiredness and weakness. Most of these side effects were also very common in children.Severe side effects affecting the brain and nervous system have also been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis. Patients should be monitored closely for these side effects and treatment stopped if necessary.For the full list of side effects and restrictions of Atriance, see the package leaflet.

Why is Atriance authorised in the EU?

The European Medicines Agency decided that Atriance's benefits are greater than its risks and it can be authorised for use in the EU. The Agency noted that, due to the small number of patients with these diseases, the information to support the authorisation of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive bone-marrow transplantation, increasing their chances of survival.Atriance has been authorised under 'exceptional circumstances'. This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance. Every year, the Agency will review any new information that may become available and this overview will be updated as necessary.

What information is still awaited for Atriance?

Since Atriance has been authorised under exceptional circumstances, the company that markets Atriance will provide yearly updates from a study on the effectiveness and safety of Atriance in children and young adults.

What measures are being taken to ensure the safe and effective use of Atriance?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atriance have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Atriance are continuously monitored. Side effects reported with Atriance are carefully evaluated and any necessary action taken to protect patients.


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Aubagio


What is Aubagio and what is it used for?

Aubagio is a medicine that contains the active substance teriflunomide. It is used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).

How is Aubagio used?

Aubagio can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.Aubagio is available as tablets. The recommended dose for adults is 14 mg once a day. The dose for children depends on their body weight. For more information about using Aubagio, see the package leaflet or contact your doctor or pharmacist.

How does Aubagio work?

In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths. The active substance in Aubagio, teriflunomide, blocks an enzyme called 'dihydro-orotate dehydrogenase' which is necessary for cells to multiply. The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.

What benefits of Aubagio have been shown in studies?

Aubagio has been studied in five main studies involving over 2,900 patients with relapsing-remitting MS.One study involving 179 adults compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan.Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.Two studies involving 2,257 adults compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the 'annualised relapse rate'). Treatment lasted for up to about three years (152 weeks). Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo). The studies also looked at the effect of Aubagio on the changes in the patients' level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.The fourth study involving 324 adults compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment. The study lasted for up to two years. The results of the study were inconclusive. A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a. However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a. Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.Another study, involving 166 children (aged 10-17 years), was inconclusive but it did indicate that Aubagio extended the time for a relapse or a lesion to develop in the brain (which was about 72 weeks for Aubagio compared with 37 weeks for placebo). Overall, the data from adults and the results of this study support use of Aubagio in children (aged 10 and older) with relapsing-remitting MS.

What are the risks associated with Aubagio?

The most common side effects with Aubagio (which may affect more than 1 in 10 people) are headache, diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss). In general, headache, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped. For the full list of side effects reported with Aubagio, see the package leaflet.Aubagio must not be used in patients with:• severe liver disease;• severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);• poor bone marrow function or low blood cell counts (red cells, white cells or platelets);• severe active infections;• severe kidney disease that requires dialysis;• severe hypoproteinaemia (low blood protein levels).Aubagio must also not be used in pregnant women or during breast-feeding. Women who can become pregnant must not take Aubagio without using reliable contraceptive measures. For the full list of restrictions, see the package leaflet.

Why is Aubagio authorised in the EU?

The European Medicines Agency decided that Aubagio's benefits are greater than its risks and it can be authorised for use in the EU. In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsing-remitting MS. Although the effects were modest,they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a. Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a. Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body. The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk minimisation measures.

What measures are being taken to ensure the safe and effective use of Aubagio?

The company that markets Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment. The pack will also include information on a registry the company will set up to collect data on babies born to women treated with Aubagio, as well as a patient reminder card with key safety information for patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aubagio have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aubagio are continuously monitored. Side effects reported with Aubagio are carefully evaluated and any necessary action taken to protect patients.


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Avamys


What is Avamys?

Avamys is a nasal spray that contains the active substance fluticasone furoate.

What is Avamys used for?

Avamys is used to treat the symptoms of allergic rhinitis. This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing. It is often accompanied by symptoms affecting the eyes, such as irritation, watering or redness. Avamys is for use in patients aged six years and over.The medicine can only be obtained with a prescription.

How is Avamys used?

The recommended dose of Avamys for patients aged 12 years and over is two sprays in each nostril once a day. This can be reduced to one spray in each nostril once symptoms are controlled. The lowest effective dose that keeps symptoms controlled should be used.For children between six and 12 years of age, the recommended dose is one spray in each nostril once a day, although this can be increased to two sprays if symptoms are not controlled.To get the most benefit from the medicine, it should be used regularly and at the same time every day. It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit. Avamys should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.

How does Avamys work?

The active substance in Avamys, fluticasone furoate, is a corticosteroid. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.

How has Avamys been studied?

The effects of Avamys were first tested in experimental models before being studied in humans. Avamys was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients. The first four studies looked at Avamys used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis(hay fever), while the fourth lasted four weeks and involved 302 patients with perennial (non-seasonal) allergies, such as allergies to animals. The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.In all of the studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose. Each symptom was measured on a scale from 0 to 3, with a maximum total score of 12.

What benefit has Avamys shown during the studies?

Avamys was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over. In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Avamys reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo. In the study of perennial allergic rhinitis, Avamys had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.Similar results were seen in children aged six years and above. However, it was not possible to determine if Avamys worked in children below the age of six years, because there were too few children below this age included the studies.

What is the risk associated with Avamys?

The most common side effect with Avamys (seen in more than 1 patient in 10) is epistaxis(nosebleeds). This is generally mild or moderate and tends to affect adults who have used Avamys for more than six weeks. For the full list of all side effects reported with Avamys, see the Package Leaflet. Avamys should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.

Why has Avamys been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Avamys's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over. The Committee recommended that Avamys be given marketing authorisation.


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Avastin


What is Avastin and what is it used for?

Avastin is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines:• cancer of the colon (large intestine) or rectum that is metastatic (has spread to other parts of the body), in combination with chemotherapy medicines that include a 'fluoropyrimidine';• metastatic breast cancer, in combination with paclitaxel or capecitabine;• advanced non-small cell lung cancer in patients whose cancer cells are not mainly of the squamous type, where it is given with platinum-based chemotherapy;• advanced non-small cell lung cancer in patients whose cancer cells have a certain change('activating mutations') in the gene for a protein called EGFR, where it is given in combination with erlotinib;• advanced or metastatic kidney cancer, in combination with interferon alfa-2a;• epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen). Avastin is used in combination with certain chemotherapy medicines in newly diagnosed patients when the cancer is advanced, or in previously treated patients whose cancer has come back (recurrent).•Avastin contains the active substance bevacizumab.

How is Avastin used?

Avastin can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer treatments.Avastin is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The first infusion of Avastin should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well. The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated. The treatment is continued until the patient no longer benefits from it. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.

How does Avastin work?

The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow. By attaching to VEGF, Avastin stops it having an effect. As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.

What benefits of Avastin have been shown in studies?

Several studies have shown that Avastin is effective at treating the types of cancers for which it is approved. In all of the studies, the main measure of effectiveness was either overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).Cancer of the colon or rectumIn metastatic cancer of the colon or rectum, Avastin used with chemotherapy including a fluoropyrimidine has been shown to increase overall and progression-free survival in three main studies. The first two studies involved patients whose metastatic disease was being treated for the first time ('first-line' treatment): in the first study (923 patients),the average overall survival was 20.3 months in patients adding Avastin and 15.6 months in those receiving chemotherapy alone; in the second study in 1,401 patients, progression-free survival was 9.4 months in patients adding Avastin and 8.0 months in those receiving chemotherapy alone. The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan. Overall survival was 12.9 months in patients adding Avastin and 10.8 months in those receiving chemotherapy alone.Breast cancerIn metastatic breast cancer, Avastin has been shown to increase progression-free survival in two main studies. In the first study (722 patients), progression-free survival was 11.4 months in patients receiving Avastin with paclitaxel, compared with 5.8 months in those receiving paclitaxel alone. In the second study (1,237 patients), when Avastin was added to capecitabine, the average progression-free survival was 8.6 months, compared with 5.7 months in those receiving capecitabine with placebo.Non-small cell lung cancer• In advanced, metastatic or recurrent lung cancer, Avastin plus platinum-based chemotherapy has been shown to increase overall survival in one study in 878 patients: the average overall survival was 12.3 months in the patients taking Avastin with platinum-based chemotherapy, and 10.3 months for those taking chemotherapy alone.• In patients with a certain subtype of non-small cell lung cancer with activating mutations in the EGFR gene, Avastin plus erlotinib has been shown to increase progression-free survival in one study in 152 patients: patients on Avastin plus erlotinib had progression-free survival of 16.0 months on average compared with 9.7 months in patients given erlotinib alone.Kidney cancerIn advanced or metastatic kidney cancer, Avastin plus interferon alfa-2a has been shown to increase progression-free survival in one study in 649 patients: the average progression-free survival was 10.2 months in the patients receiving Avastin plus interferon alfa-2a and 5.4 months in those receiving interferon alfa-2a.Ovarian, fallopian tube and peritoneal cancer• Newly diagnosed disease (including advanced disease, first-line treatment): in newly diagnosed ovarian, fallopian tube and peritoneal cancer, Avastin, in combination with carboplatin and paclitaxel, has been shown to increase progression-free survival in two main studies involving 3,401 patients: the average progression-free survival was 19.3 months in patients adding Avastin versus 16.9 months with carboplatin and paclitaxel alone in one study, and 14.7 months versus 10.6 months in the second study.• Recurrent disease: three studies with Avastin in recurrent ovarian, fallopian tube and peritoneal cancers were performed in a total of 1,518 patients. The first two studies included patients whose cancer came back 6 months or more after previous treatment ('platinum-sensitive disease'), while the third study was in patients with more aggressive cancer that had come back within 6 months of previous treatment ('platinum-resistant disease'). In the first study, average progression-free survival was 12.4 months when Avastin was added to carboplatin and gemcitabine, compared with8.4 months when placebo was added. In the second study, overall survival in patients given Avastin in combination with carboplatin and paclitaxel was 42.6 months, compared with 37.3 months in patients treated with carboplatin and paclitaxel only. In the third study in patients with more aggressive cancer, progression-free survival was 6.7 months when Avastin was added to paclitaxel, topotecan, or pegylated liposomal doxorubicin, compared with 3.4 months when these chemotherapies were used on their own.Cervical cancerIn cancer of the cervix, Avastin has been shown to increase overall survival in one main study involving 452 patients with advanced persistent, recurrent or metastatic cancer of the cervix. The study compared the effect of adding Avastin to chemotherapy using paclitaxel plus cisplatin or topotecan to results in patients given chemotherapy alone.Results showed that the average overall survival was 16.8 months with chemotherapy including Avastin compared with 12.9 months on chemotherapy alone. When the type of chemotherapy was taken into account, there was a tendency for patients given cisplatin-based treatment to live on average about 2 months longer than those given topotecan-based treatment, independently of giving Avastin as part of the treatment regimens.

What is the risk associated with Avastin?

The most common side effects with Avastin are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Avastin, see the package leaflet.Avastin must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies. It must not be given to pregnant women.

Why has Avastin been approved?

The CHMP decided that Avastin's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Avastin?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avastin have been included in the summary of product characteristics and the package leaflet.


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Avonex


What is Avonex and what is it used for?

Avonex is a medicine used to treat:• patients with relapsing multiple sclerosis (MS). MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. In relapsing MS, the patient has attacks (relapses) between periods with no symptoms. Avonex slows the progression of disability and reduces the number of relapses;• patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines). It is used when the patient is considered to be at high risk of developing MS. Before using Avonex, doctors need to exclude other causes for the symptoms.Avonex contains the active substance interferon beta-1a.

How is Avonex used?

Avonex can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.Avonex is available as a solution for injection in a pre-filled syringe or pre-filled pen. Each syringe and pen contains 30 micrograms of interferon beta-1a.In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week. To help patients adjust to treatment, the doctor may recommend that patients start with a lower dose once a week before increasing to the full dose. This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.The site of injection should be changed each week. Patients can inject Avonex themselves once they have been trained. A painkiller that prevents fever can be given before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur during the first few months of treatment. Avonex treatment should be stopped in patients who develop progressive (worsening) MS.For more information about using Avonex, see the package leaflet or contact your doctor or pharmacist.

How does Avonex work?

The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks. In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them. The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.

What benefits of Avonex have been shown in studies?

Avonex has been compared with placebo (a dummy treatment) in two main studies. The first study involved 301 patients aged 16 years and older with relapsing MS who had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years. Treatment continued for up to two years. The main measure of effectiveness was the number of patients whose disability got worse. After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack. The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.The company has not carried out any formal studies of patients under 16 years of age. However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years, which showed that they had a decrease in the rate of relapse, possibly due to Avonex treatment.

What are the risks associated with Avonex?

The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating. These side effects decrease with continued treatment. The side effects are similar in adults and in children.Avonex must not be used in patients who have severe depression or have thoughts of suicide.For the full list of side effects and restrictions with Avonex, see the package leaflet.

Why is Avonex authorised in the EU?

The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Avonex?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avonex have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Avonex are continuously monitored. Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.


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Axumin


What is Axumin and what is it used for?

Axumin is a diagnostic medicine used with a body scan to check whether or not prostate cancer has returned.It is used specifically with the body scan known as positron-emission tomography (PET) in men whose blood test for prostate-specific antigen (PSA) indicate that the cancer may have returned.Axumin is a 'radiopharmaceutical': it contains the active substance fluciclovine (18F), which emits a small amount of radiation.

How is Axumin used?

Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.Axumin can only be obtained with a prescription. The PET images must be read by nuclear medicine physicians trained in interpreting PET scan images with Axumin. Patients should discuss the results of their PET scan with their doctor. For further information, see the package leaflet.

How does Axumin work?

The active substance in Axumin, fluciclovine (18F), works by entering prostate cancer cells via structures (LAT-1 and ASCT2) that are present in high numbers on the surface of these cells. Once inside the cancer cells, it emits radiation which is detected on the PET scan, enabling doctors to see where the cancer is located.

What benefits of Axumin have been shown in studies?

In a main study involving medical records from 115 men, PET scans with Axumin correctly detected cancers in 99% of all patients whose cancer had in fact returned (as confirmed by tissue sampling). When the scans from this study were looked at by another team of researchers, the scans were again shown to be able to detect cancer in most patients who had it. (87% of patients with cancer had positive scans.)However, because some scans with Axumin were falsely positive (showing that cancer had returned when tissue sampling was negative), a positive result on its own is not enough to make a diagnosis. Depending on the person reading the scans, only 17 to 54% of patients whose tissue samples did not show cancer had a negative scan result.All men enrolled in this study had already shown some signs that the cancer might have returned, such as increases in blood levels of PSA, a protein produced in the prostate glands. The accuracy of the scans varied depending on the PSA levels.

What are the risks associated with Axumin?

The most common side effects with Axumin (seen in between 1 and 10 patients in 100) are taste disturbances, altered sense of smell, and pain or rash at the site of injection. For the full list of side effects and restrictions reported with Axumin, see the package leaflet.Axumin delivers a very low amount of radiation which could pose a very low risk of cancer and hereditary abnormalities.

Why is Axumin approved?

PET scans with Axumin are effective in detecting prostate cancer and can help exclude the presence of the cancer. The side effects seen with the product are mild and rare, and there are no serious safety risks. Furthermore, the risk from radiation is very low.The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Axumin's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Axumin?

The company that markets Axumin will ensure that all healthcare professional expected to use this product have access to education material to reduce errors in interpreting PET scan images.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Axumin have also been included in the summary of product characteristics and the package leaflet.


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Axura


What is Axura?

Axura is a medicine that contains the active substance memantine hydrochloride. It is available as tablets (5 mg, 10 mg, 15 mg and 20 mg). Axura is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.

What is Axura used for?

Axura is used to treat patients with moderate to severe Alzheimer's disease. Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.The medicine can only be obtained with a prescription.

How is Axura used?

Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease. Treatment should only be started if a caregiver is available who will regularly monitor the use of Axura by the patient.Axura should be given once a day, at the same time every day. To prevent side effects, the dose ofAxura is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuingtreatment with Axura should be reassessed on a regular basis. The dose may need to be reduced in patients who have moderate or severe problems with their kidneys. If the solution is used, the dose should first be pumped onto a spoon or into a glass of water. It should not be poured or pumped directly into the mouth. For more information, see the package leaflet.

How does Axura work?

The active substance in Axura, memantine hydrochloride, is an antidementia medicine. The cause of Alzheimer's disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.Memantine works by blocking special types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another. Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease. In addition, overstimulation of the NMDA receptors can result in cell damage or death. By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.

How has Axura been studied?

Axura has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease. Axura was compared with placebo (a dummy treatment) over 24 to 28 weeks. The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.

What benefit has Axura shown during the studies?

Axura was more effective than placebo at controlling the symptoms of Alzheimer's disease. In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores. In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores. However, when these results were considered along with those of the three additional studies, it was noted that the effect of Axura was smaller in patients with mild disease.

What is the risk associated with Axura?

The most common side effects with Axura (seen in between 1 and 10 patients in 100) are somnolence(sleepiness), dizziness, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache and drug hypersensitivity (allergy to the medicine). For the full list of all side effects reported with Axura, see the package leaflet.Axura must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.

Why has Axura been approved?

The CHMP decided that Axura's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Aybintio


What is Aybintio and what is it used for?

Aybintio is a cancer medicine that is used to treat adults with the following cancers:• cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;• breast cancer that has spread to other parts of the body;• a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Aybintio can be used in non-small cell lung cancer unless it originates in cells of a particular type (called squamous cells);• cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;• cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb and the peritoneum, the membrane that lines the abdomen) that is advanced or has come back after treatment;• cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.Aybintio is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.Aybintio is a 'biosimilar medicine'. This means that Aybintio is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Aybintio is Avastin. For more information on biosimilar medicines, see here.Aybintio contains the active substance bevacizumab.

How is Aybintio used?

Aybintio can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.Aybintio is given by infusion (drip) into a vein. The first infusion of Aybintio should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion has not caused unacceptable sideeffects. The dose depends on the patient's weight, the type of cancer being treated and the other cancer medicines being used. Treatment is continued for as long as the patient benefits from it. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.For more information about using Aybintio, see the package leaflet or contact your doctor or pharmacist.

How does Aybintio work?

The active substance in Aybintio, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes new blood vessels grow. By attaching to VEGF, Aybintio stops its effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.

What benefits of Aybintio have been shown in studies?

Laboratory studies comparing Aybintio with Avastin have shown that the active substance in Aybintio is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Aybintio produces similar levels of the active substance in the body to giving Avastin.In addition, a study involving 763 patients with advanced non-small cell lung cancer showed thatAybintio was as effective as Avastin when given with the cancer medicines paclitaxel and carboplatin. The cancer responded to treatment in 50% of those given Aybintio and 45% of those given Avastin, which was considered comparable.Because Aybintio is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Aybintio.

What are the risks associated with Aybintio?

The safety of Aybintio has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Avastin.The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Aybintio, see the package leaflet.Aybintio must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant (genetically engineered) antibodies. It must not be given to pregnant women.

Why is Aybintio authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Aybintio has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way. In addition, studies in non-small cell lung cancer have shown that the safety and effectiveness of Aybintio is equivalent to that of Avastin in this indication.All these data were considered sufficient to conclude that Aybintio will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Avastin, the benefits of Aybintio outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aybintio?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aybintio have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Aybintio are continuously monitored. Side effects reported with Aybintio are carefully evaluated and any necessary action taken to protect patients.


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Ayvakyt


What is Ayvakyt and what is it used for?

Ayvakyt is a cancer medicine used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, that cannot be removed by surgery and has spread to other parts of the body. Ayvakyt is used when the cancer cells have a D842V mutation, a change in the gene for the plateletderived growth factor receptor alpha (PDGFRA).Ayvakyt is also used in adults with advanced systemic mastocytosis, which means any of the following disorders of a type of white blood cell known as mast cells: aggressive systemic mastocytosis, systemic mastocytosis associated with a haematological neoplasm (blood cancer), or mast cell leukaemia. It is used after the patient has received at least one systemic treatment (treatment with medicines affecting the whole body).These diseases are rare, and Ayvakyt was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 July 2017 (GIST) and on 26 October 2018 (mastocytosis).Ayvakyt contains the active substance avapritinib.

How is Ayvakyt used?

Ayvakyt is available as tablets to be taken by mouth and can only be obtained with a prescription. Treatment should be started and supervised by a specialist doctor experienced in the use of cancer treatments.Ayvakyt should be taken on an empty stomach. The recommended dose is 300 mg once a day for GIST and 200 mg once a day for advanced systemic mastocytosis. The dose may need to be reduced if the patient is taking other medicines called 'CYP3A inhibitors' that could interfere with the way Ayvakyt is broken down in the body. Treatment may be paused, stopped or the dose reduced if the patient experiences certain side effects.For more information about using Ayvakyt, see the package leaflet or contact your doctor or pharmacist.

How does Ayvakyt work?

Ayvakyt is one of a group of medicines called receptor tyrosine kinase inhibitors. It works by blocking the activity of receptors (targets) called PDGFRA on the surface of GIST or mast cells. These receptors help to control cell growth and can be abnormal (mutated) in GIST and mast cells, causing the cells to multiply uncontrollably. By blocking the action of the abnormal receptor, the medicine is expected to help to slow down the growth of these cells.

What benefits of Ayvakyt have been shown in studies?

GISTAyvakyt showed benefit in one main study involving 38 patients with GIST where the cancer cells had the D842V PDGFRA mutation. In the study, in which Ayvakyt was not compared with any other medicine, the disease responded to treatment in 95% of patients (36 out of 38) and it took on average 22 months before the cancer got worse in treated patients.Advanced systemic mastocytosisFor advanced systemic mastocytosis, Ayvakyt showed benefit in one ongoing main study: out of 47 patients with advanced systemic mastocytosis who received previous systemic therapy, 28 (60%) responded to treatment with Ayvakyt. Although patients have been followed for a limited period it is expected that response will last on average for at least 12 months.

What are the risks associated with Ayvakyt?

In patients with GIST, the most common side effects with Ayvakyt (affecting more than 20 in 100 people) are nausea (feeling sick), tiredness, anaemia (low red blood cell counts), periorbital, face or peripheral oedema (swelling of the eyes, face, ankles or feet), hyperbilirubinaemia (high blood levels of bilirubin indicating liver problems), diarrhoea, vomiting, increased lacrimation (watery eyes), decreased appetite and memory impairment (forgetfulness).The most common serious side effects with Ayvakyt in patients with GIST (which may affect up to 6 in 100 people) are anaemia and pleural effusion (fluid around the lungs).In patients with advanced systemic mastocytosis , the most common side effects (affecting more than 20 in 100 people) are periorbital and peripheral oedema, thrombocytopenia (low blood platelet counts) and anaemia.The most common serious side effects (which may affect up to 2 in 100 people) are subdural haematoma (collection of blood between the skull and surface of the brain), anaemia and bleeding.For the full list of side effects and restrictions with Ayvakyt, see the package leaflet.

Why is Ayvakyt authorised in the EU?

The European Medicines Agency decided that Ayvakyt's benefits are greater than its risks and it can be authorised for use in the EU.Ayvakyt benefited a high proportion of patients with GIST with a D842V PDGFRA mutation for a significant length of time. Similar results have not been seen before and are better than those reported in the literature for other medicines of the same type in this patient population, who do not have a lot of treatment options. Although Ayvakyt also had substantial side effects, these were mostly similar to those of other medicines of the same type and were considered manageable.For advanced systemic mastocytosis, where treatment options are also limited, the benefits were promising and clinically meaningful while the overall safety profile appears consistent with that seen for GIST.Ayvakyt has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Ayvakyt?

Since Ayvakyt has been given conditional authorisation, the company that markets Ayvakyt will provide additional results on the safety and effectiveness of the medicine from 2 ongoing studies in GIST, and will also carry out a study of the medicine as it is used by patients with GIST in the real-life setting.

What measures are being taken to ensure the safe and effective use of Ayvakyt?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ayvakyt have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Ayvakyt are continuously monitored. Side effects reported with Ayvakyt are carefully evaluated and any necessary action taken to protect patients.


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Azacitidine Accord


What is Azacitidine Accord and what is it used for?

Azacitidine Accord is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):• myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Accord is used in patients with an intermediate to high risk of progressing to AML or death;• chronic myelomonocytic leukaemia (a cancer affecting white blood cells called monocytes). Azacitidine Accord is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;• AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;• AML, when the bone marrow has more than 30% abnormal cells.Azacitidine Accord contains the active substance azacitidine.Azacitidine Accord is a 'generic medicine'. This means that Azacitidine Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Vidaza. For more information on generic medicines, see the question-and-answer document here.

How is Azacitidine Accord used?

The medicine can only be obtained with a prescription.Azacitidine Accord treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Patients should receive medicines to prevent nausea (feeling sick) and vomiting before receiving Azacitidine Accord.The recommended dose of Azacitidine Accord depends on the patient's height and weight. It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment. This four-week period is one 'cycle'. Treatment continuesSendfor at least six cycles and then for as long as it benefits the patient. The liver, kidneys and blood should be checked before each cycle. If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.For more information about using Azacitidine Accord, see the package leaflet or contact your doctor or pharmacist.

How does Azacitidine Accord work?

The active substance in Azacitidine Accord, azacitidine, belongs to the group 'anti-metabolites'. Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by changing the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA. These actions are expected to correct problems with the maturation and growth of blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.

How has Azacitidine Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Vidaza, and do not need to be repeated for Azacitidine Accord.As for every medicine, the company provided studies on the quality of Azacitidine Accord. There was no need for 'bioequivalence' studies to investigate whether Azacitidine Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Azacitidine Accord is the same as the reference medicine and when given by injection under the skin, the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Azacitidine Accord?

Because Azacitidine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Azacitidine Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, AzacitidineAccord has been shown to be comparable to Vidaza. Therefore, the Agency's view was that, as for Vidaza, the benefits of Azacitidine Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Azacitidine Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Azacitidine Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Azacitidine Accord are continuously monitored. Side effects reported with Azacitidine Accord are carefully evaluated and any necessary action taken to protect patients.


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Azacitidine Betapharm


What is Azacitidine betapharm and what is it used for?

Azacitidine betapharm is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient's bone marrow is replaced to form new bone marrow that produces healthy cells):• myelodysplastic syndromes, a group of conditions where the bone marrow produces abnormal blood cells and not enough healthy ones. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells).Azacitidine betapharm is used in patients with an intermediate to high risk of progressing to AML or death;• chronic myelomonocytic leukaemia (a cancer affecting white blood cells called monocytes). Azacitidine betapharm is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;• AML that has developed from a myelodysplastic syndrome, where the bone marrow consists of 20 to 30% abnormal cells;• AML, where the bone marrow has more than 30% abnormal cells.Azacitidine betapharm contains the active substance azacitidine.Azacitidine betapharm is a 'generic medicine'. This means that Azacitidine betapharm contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Vidaza. For more information on generic medicines, see the question-and-answer document here.

How is Azacitidine betapharm used?

Azacitidine betapharm can only be obtained with a prescription and treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Before receiving Azacitidine betapharm, patients should receive medicines to prevent nausea (feeling sick) and vomiting.SendThe recommended dose of Azacitidine betapharm depends on the patient's height and weight. It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for 1 week, followed by 3 weeks with no treatment. This 4-week period is one 'cycle'. Treatment is given for at least 6 cycles and, if it is working, it is continued for as long as it benefits the patient. The liver, kidneys and blood should be checked before each cycle. If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed, or a lower dose should be used.For more information about using Azacitidine betapharm, see the package leaflet or contact your doctor or pharmacist.

How does Azacitidine betapharm work?

The active substance in Azacitidine betapharm, azacitidine, belongs to the group 'anti-metabolites'. Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by changing the way the cell turns genes on and off and by interfering with the production of new RNA and DNA. These actions are expected to correct problems with the development of blood cells in the bone marrow that cause myelodysplastic disorders and to kill cancerous cells in leukaemia.

How has Azacitidine betapharm been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Vidaza, and do not need to be repeated for Azacitidine betapharm.As for every medicine, the company provided studies on the quality of Azacitidine betapharm. There was no need for 'bioequivalence' studies to investigate whether Azacitidine betapharm is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Azacitidine betapharm is the same as that of the reference medicine and, when given by injection under the skin, the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Azacitidine betapharm?

Because Azacitidine betapharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Azacitidine betapharm authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Azacitidine betapharm has been shown to be comparable to Vidaza. Therefore, the Agency's view was that, as for Vidaza, the benefits of Azacitidine betapharm outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Azacitidine betapharm?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Azacitidine betapharm have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Azacitidine betapharm are continuously monitored. Side effects reported with Azacitidine betapharm are carefully evaluated and any necessary action taken to protect patients.


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Azacitidine Mylan


What is Azacitidine Mylan and what is it used for?

Azacitidine Mylan is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient's bone marrow is replaced to form new bone marrow that produces healthy cells):• myelodysplastic syndromes, a group of conditions where the bone marrow produces abnormal blood cells and not enough healthy ones. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Mylan is used in patients with an intermediate to high risk of progressing to AML or death;• chronic myelomonocytic leukaemia (a cancer affecting white blood cells called monocytes). Azacitidine Mylan is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;• AML that has developed from a myelodysplastic syndrome, where the bone marrow consists of 20 to 30% abnormal cells;• AML, where the bone marrow has more than 30% abnormal cells.Azacitidine Mylan contains the active substance azacitidine.Azacitidine Mylan is a 'generic medicine'. This means that Azacitidine Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Vidaza. For more information on generic medicines, see the question-and-answer document here.

How is Azacitidine Mylan used?

Azacitidine Mylan can only be obtained with a prescription and treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Before receiving Azacitidine Mylan, patients should receive medicines to prevent nausea (feeling sick) and vomiting.The recommended dose of Azacitidine Mylan depends on the patient's height and weight. It is given as an injection under the skin of the upper arm, thigh or abdomen (belly) every day for 1 week, followedSendby 3 weeks with no treatment. This 4-week period is one 'cycle'. Treatment is given for at least 6 cycles and, if it is working, it is continued for as long as it benefits the patient. The liver, kidneys and blood should be checked before each cycle. If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.For more information about using Azacitidine Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Azacitidine Mylan work?

The active substance in Azacitidine Mylan, azacitidine, belongs to the group 'anti-metabolites'. Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by changing the way the cell turns genes on and off and by interfering with the production of new RNA and DNA. These actions are expected to correct problems with the development of blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.

How has Azacitidine Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Vidaza, and do not need to be repeated for Azacitidine Mylan.As for every medicine, the company provided studies on the quality of Azacitidine Mylan. There was no need for 'bioequivalence' studies to investigate whether Azacitidine Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Azacitidine Mylan is the same as that of the reference medicine and, when given by injection under the skin, the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Azacitidine Mylan?

Because Azacitidine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Azacitidine Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Azacitidine Mylan has been shown to be comparable to Vidaza. Therefore, the Agency's view was that, as for Vidaza, the benefits of Azacitidine Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Azacitidine Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Azacitidine Mylan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Azacitidine Mylan are continuously monitored. Side effects reported with Azacitidine Mylan are carefully evaluated and any necessary action taken to protect patients.


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Azarga


What is Azarga?

Azarga is a medicine that contains two active substances, brinzolamide and timolol. It is available as eye drops.

What is Azarga used for?

Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye). It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal). Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.The medicine can only be obtained with a prescription.

How is Azarga used?

Azarga is given as one drop into the affected eye(s) twice a day. The suspension needs to be shaken well before use. If it is used with another eye medicine, the different medicines should be used at least 5 minutes apart. If the other eye medicine is an eye ointment it should be used last.

How does Azarga work?

Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, Azarga reduces the risk of damage.Azarga contains two active substances, brinzolamide and timolol. The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways. Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body. Bicarbonate is required for the production of the aqueous humour. Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000. Timolol is a beta blocker that has been commonly used to treat glaucoma since the 1970s. The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.

How has Azarga been studied?

Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension. The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients. The second was a 12-month study comparing Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients. In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment. IOP was measured in 'millimetres of mercury' (mmHg).

What benefit has Azarga shown during the studies?

Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide. In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga. This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol. In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.

What is the risk associated with Azarga?

The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are blurred vision, eye pain and eye irritation. For the full list of all side effects reported with Azarga, see the package leaflet.Azarga must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, other beta blockers (such as some heart medicines) or sulphonamides (an antibiotic). It must not be used by patients who:• have or have had asthma;• have severe chronic obstructive pulmonary disease (COPD, a disease causing narrowing of the airways);• have certain heart problems;• have a severe allergic rhinitis (allergy affecting the nose and airways);• have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);• have severely reduced kidney function.For the full list of restrictions, see the package leaflet.Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses.

Why has Azarga been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment. The Committee decided that Azarga's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Azarga?

A risk management plan has been developed to ensure that Azarga is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Azarga, including the appropriate precautions to be followed by healthcare professionals and patients.


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Azilect


What is Azilect?

Azilect is a medicine that contains the active substance rasagiline. It is available as tablets (1 mg).

What is Azilect used for?

Azilect is used to treat Parkinson's disease. Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Azilect can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having 'fluctuations' towards the end of the period between levodopa doses. Fluctuations are linked to a reduction in the effects of levodopa, when the patient experiences sudden switches between being 'on' and able to move, and being 'off' and immobile.Azilect can only be obtained with a prescription.

How is Azilect used?

The standard dose of Azilect is one tablet once a day.

How does Azilect work?

The active substance in Azilect, rasagiline, is a 'monoamine oxidase-B inhibitor'. It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells. In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, Azilect improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.

How has Azilect been studied?

Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease. In the first study, two different doses of Azilect taken alone were compared with placebo (a dummy treatment) in 404 patients with early-stage disease. The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson's Disease Rating Scale, UPDRS).The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients' existing treatment including levodopa. It was compared with placebo or entacapone (another medicine for Parkinson's disease). The studies lasted 26 and 18 weeks, respectively. The main measure of effectiveness was the time spent in the 'off' state during the day, as recorded in patients' diaries.

What benefit has Azilect shown during the studies?

Azilect was more effective than placebo in all of the studies. In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69. This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54. A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.When used as an add-on to levodopa, 1 mg Azilect reduced the time in the 'off' state more than placebo did. In both studies, patients adding Azilect spent an average of around one hour less in the 'off' state than those adding placebo. A similar decrease in time spent in the 'off' state was seen in patients taking entacapone.

What is the risk associated with Azilect?

The most common side effect with Azilect (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Azilect, see the package leaflet.Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations obtained without prescription such as St John's wort. It must also not be used with pethidine (a painkiller). There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or with pethidine. Azilect must not be used in patients who have severe problems with their liver. For the full list of restrictions, see the package leaflet.

Why has Azilect been approved?

The CHMP decided that Azilect's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Azomyr


What is Azomyr?

Azomyr is a medicine containing the active substance desloratadine. It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a0.5 mg/ml oral solution.

What is Azomyr used for?

Azomyr is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).The medicine can only be obtained with a prescription.

How is Azomyr used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day. The dose in children depends on their age. For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution. For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet. Adults and adolescents can use any form of the medicine.

How does Azomyr work?

The active substance in Azomyr, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Azomyr been studied?

Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma). The effectiveness of Azomyr was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.Azomyr has also been studied in 416 patients with urticaria. The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment).Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.

What benefit has Azomyr shown during the studies?

In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo. In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients.

What is the risk associated with Azomyr?

In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%). The side effects seen in children are similar. In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%). For the full list of all side effects reported with Azomyr, see the Package Leaflet.Azomyr must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.

Why has Azomyr been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria. The Committee recommended that Azomyr be given marketing authorisation.


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Azopt


What is Azopt?

Azopt is a medicine that contains the active substance brinzolamide. It is available as an eye drop suspension.

What is Azopt used for?

Azopt is used to reduce the pressure inside the eye. It is used in patients with ocular hypertension (when the pressure in the eye is higher than normal) or open-angle glaucoma (a disease in which the pressure inside the eye rises because fluid cannot drain out of the eye). Azopt is used as an add-on to beta blockers or prostaglandin analogues (other medicines used for these conditions), or on its own in patients who cannot take or do not respond to beta blockers.The medicine can only be obtained with a prescription.

How is Azopt used?

The dose of Azopt is one drop into the affected eye(s) twice a day. Some patients may have a better response with one drop three times a day. The suspension needs to be shaken before use. If more than one type of eye-drop medicine is being used, each one should be given at least five minutes apart.

How does Azopt work?

Raised pressure inside the eye causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve (the nerve that sends signals from the eye to the brain). This can result in loss of vision and even blindness. By lowering the pressure, Azopt reduces the risk of damage to these structures.The active substance in Azopt, brinzolamide, is a carbonic anhydrase inhibitor. It works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate in the body. Bicarbonate is required for the production of the aqueous humour (the watery fluid in the eye). By blocking the production of bicarbonate in the eye, Azopt slows down the production of aqueous humour, reducing the pressure inside the eye.

How has Azopt been studied?

Azopt has been studied in seven main studies including a total of 2,173 patients with open-angle glaucoma or ocular hypertension.In three of the studies, Azopt, used on its own two or three times a day, was compared with timolol (a beta-blocker) and with dorzolamide (another carbonic anhydrase inhibitor). Two of the studies compared adding Azopt, dorzolamide or placebo (a dummy treatment) to timolol, and the final two studies compared Azopt used twice a day with timolol, when they were used as an add-on to travoprost (a prostaglandin analogue). All of the studies lasted for three months, except for the study comparing Azopt used on its own with timolol, which lasted for 18 months.In all of the studies, the main measure of effectiveness was the change in pressure inside the eye, measured in units called 'millimetres of mercury' (mmHg). The eye pressure was at least 21 mmHg in all of the patients at the start of the studies (above the normal range of 10 to 21 mmHg).

What benefit has Azopt shown during the studies?

When used on its own, Azopt was less effective than timolol. Azopt caused a reduction in eye pressure of between 2.7 and 5.7 mmHg over 18 months, compared with a reduction of between 5.2 and 6.0 mmHg with timolol.Azopt was as effective as dorzolamide when used on its own or as an add-on to timolol, with decreases in pressure of between 3.4 and 5.7 mmHg. Dorzolamide led to decreases of between 4.3 and 4.9 mmHg. Azopt was also more effective than placebo when used as an add-on to timolol.When used as an add-on to travoprost, Azopt had a similar effect to timolol in reducing eye pressure. In both studies, adding either Azopt or timolol caused a further decrease in eye pressure of around 3.5 mmHg after 12 weeks.Overall, Azopt showed a similar effect when used two or three times a day. However, the results suggested that some patients may show a greater reduction in eye pressure when using the drops three times a day.

What is the risk associated with Azopt?

The most common side effects with Azopt (seen in more than 1 patient in 20) are dysgeusia (a bitter or unusual taste in the mouth) and temporary blurring of vision. For the full list of all side effects reported with Azopt, see the package leaflet.Azopt must not be used in people who are hypersensitive (allergic) to brinzolamide or any of the other ingredients, or to other medicines called sulphonamides (such as some antibiotics). It must not be used in patients with severe kidney disease or hyperchloraemic acidosis (excess acid in the blood caused by too much chloride). For the full list of restrictions, see the package leaflet.

Why has Azopt been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Azopt's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Azopt?

A risk management plan has been developed to ensure that Azopt is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Azopt, including the appropriate precautions to be followed by healthcare professionals and patients.


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