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.

Galafold


What is Galafold and what is it used for?

Galafold is a medicine used to treat patients aged 12 years and above who have Fabry disease. This is a rare inherited disorder where patients have various mutations (changes) in the gene responsible for the production of an enzyme called alpha-galactosidase. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3). As a result of the mutations, the enzyme does not work properly and cannot break down GL-3. This leads to a build up of GL-3 in various cells in the body, including in the heart and kidneys.Fabry disease is rare, and Galafold was designated an 'orphan medicine' (a medicine used in rare diseases) on 22 May 2006. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu306368.Galafold contains the active substance migalastat.

How is Galafold used?

Galafold can only be obtained with a prescription and treatment should only be started and supervised by a doctor who is experienced in the diagnosis and treatment of Fabry disease.Galafold is available as capsules. The recommended dose of Galafold is one capsule every other day. Patients should not consume any food at least 2 hours before and 2 hours after taking Galafold to allow full absorption.Galafold is only for use in patients with certain mutations in the alpha-galactosidase A gene. For more information about using Galafold, see the package leaflet or contact your doctor or pharmacist.

How does Galafold work?

The active substance in Galafold, migalastat, attaches to certain unstable forms of alpha-galactosidase A, stabilising the enzyme. This allows the enzyme to be transported into areas of the cell where it can break down GL-3.

What benefits of Galafold have been shown in studies?

Galafold has been investigated in two main studies involving a total of 127 patients [AI1]aged over 16 yewith Fabry disease.The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who responded to treatment (defined as a reduction of at least 50% in GL-3 deposits in the kidneys). Overall, Galafold was not found to be more effective than placebo at reducing GL-3 deposits; however, additional analyses including only patients with those genetic mutations that can be treated with Galafold showed that patients responded better to Galafold than to placebo after 6 months of treatment.The second study, in 60 patients, compared Galafold with the medicines agalsidase alfa or agalsidase beta, two treatments that replace the missing enzyme. The main measure of effectiveness was the change in patients' kidney function after 18 months of treatment. In this study, Galafold was found to be as effective as enzyme replacement in stabilising patients' kidney function.The company also provided results of a study that showed that Galafold produces the same levels of the active substance in the body and has the same effect in adolescents aged 12 up to and including 15 years old as in adults and young people aged 16 and above.

What are the risks associated with Galafold?

The most common side effect with Galafold (which may affect around 1 in 10 people) is headache.For the full list of all side effects and restrictions with Galafold, see the package leaflet.

Why is Galafold authorised in the EU?

The European Medicines Agency decided that Galafold's benefits are greater than its risks and it can be authorised for use in the EU. The Agency noted that Galafold was studied in a limited number of patients, however the available evidence is considered sufficient for such a rare disease. The Agency also noted that Galafold is taken by mouth and this could be an advantage compared with other authorised treatments such as enzyme replacement which are given by infusion (drip) into a vein.Regarding safety, Galafold was well-tolerated.

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

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


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Galvus


What is Galvus and what is it used for?

Galvus is a diabetes medicine that is used together with diet and exercise to control the blood glucose (sugar) in adults with type 2 diabetes. It is used alone when metformin (another diabetes medicine) is not suitable, or together with other diabetes medicines, including insulin, when these medicines do not provide adequate control of the blood glucose.Galvus contains the active substance vildagliptin.

How is Galvus used?

Galvus can only be obtained with a prescription and is available as 50-mg tablets. The recommended dose of Galvus is:• one tablet in the morning and another in the evening (100 mg per day) when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);• one tablet in the morning (50 mg per day) when taken with a sulphonylurea. A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.Because vildagliptin has been associated with liver problems, the doctor should carry out tests to check the patient's liver function before treatment with Galvus and at regular intervals during treatment.For more information about using Galvus, see the package leaflet or contact your doctor or pharmacist.

How does Galvus 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 Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By blocking the breakdown of incretin hormones in the blood, vildagliptinprolongs their action, stimulating the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low.Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

What benefits of Galvus have been shown in studies?

Galvus on its own or as an add-on treatment has been studied in 11 main studies involving a total of over 6,000 patients with type 2 diabetes and insufficient control of blood glucose levels. In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.Galvus was effective at reducing levels of HbA1c but was less effective than metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea). In a study comparing Galvus with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Galvus.When used as an add-on to metformin and to pioglitazone (a thiazolidinedione), Galvus reduced HbA1c levels by 0.8 to 1.0 percentage points. When used with glimepiride (a sulphonylurea), Galvus caused a reduction of around 0.6 percentage points. In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.As an add-on to metformin plus glimepiride, Galvus reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.Finally, when used as an add-on to insulin treatment, Galvus caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect in one study was small, possibly due to the fact that the study included long-term patients who were less likely to show improvement. However, in another study, the size of this effect was significant. Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.

What are the risks associated with Galvus?

The most common side effect with Galvus (which may affect up to 1 in 10 people) is dizziness. For the full list of all side effects reported with the medicine, including side effects occurring when it is taken with other diabetes medicines, see the package leaflet.For the full list of restrictions, see the package leaflet.

Why is Galvus authorised in the EU?

Studies have shown Galvus to be effective as add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin. Galvus on its own has also been shown to be effective in reducing blood glucose but less so than metformin. The medicine should therefore only be used on its own in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them. The side effects of Galvus were mostly mild and resolved over time.Galvus Galvus (vildagliptin)The European Medicines Agency decided that Galvus' 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 Galvus?

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


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Ganfort


What is Ganfort?

Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).

What is Ganfort used for?

Ganfort is used to reduce the pressure inside the eye. It is used in adults with 'open angle glaucoma' or ocular hypertension who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).'Ocular hypertension' is when the pressure in the eye is higher than normal. In open angle glaucoma the high pressure is caused by fluid being unable to drain out of the eye.The medicine can only be obtained with a prescription.

How is Ganfort used?

Ganfort is given as one drop in the affected eye(s) once a day, either in the morning or the evening. It should be given at the same time each day. If more than one type of eye drop is being used, each one should be given at least five minutes apart.

How does Ganfort work?

Raised pressure in the eye causes damage to the retina (the light sensitive membrane 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, Ganfort reduces the risk of damage.Ganfort contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways. Bimatoprost is a prostaglandin analogue, (a copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan. Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol 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 Ganfort been studied?

Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma. The studies compared Ganfort with bimatoprost, timolol, or bimatoprost and timolol given at the same time after three weeks to four months of treatment. The main measures of effectiveness were the average reduction in eye pressure or the number of patients whose eye pressure fell below the target of 18 mmHg (making it within the normal range).

What benefit has Ganfort shown during the studies?

Overall, the studies showed that Ganfort is effective in lowering eye pressure. The values were lowered by about 8-10 mmHg. Ganfort was more effective than timolol on its own and was as effective as bimatoprost.Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone. Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only. In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%).In addition, Ganfort was shown to be as effective as bimatoprost and timolol given at the same time.

What is the risk associated with Ganfort?

The most common side effect (seen in more than 1 patient in 10) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye). For the full list of all side effects reported with Ganfort, see the package leaflet.Ganfort must not be used in patients who have asthma or severe lung disease, or in patients with some heart conditions. See the package leaflet for the full list of restrictions.

Why has Ganfort been approved?

The CHMP decided that Ganfort'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 Ganfort?

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


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Ganirelix Gedeon Richter


What is Ganirelix Gedeon Richter and what is it used for?

Ganirelix Gedeon Richter is a medicine used to prevent premature ovulation (early release of eggs from the ovary) in women having fertility treatment and who are having ovarian stimulation (stimulation of the ovaries so that they produce more eggs).Ganirelix Gedeon Richter contains the active substance ganirelix and is a 'generic medicine'. This means that the medicine contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Orgalutran. For more information on generic medicines, see the question-and-answer document here.

How is Ganirelix Gedeon Richter used?

Ganirelix Gedeon Richter can only be obtained with a prescription and should only be prescribed by a doctor experienced in the treatment of infertility.Ganirelix Gedeon Richter is available in prefilled syringes as a solution for injection. The injection is given once a day under the skin and treatment should start on day 5 or 6 after the start of ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin alfa (a modified FSH). When treatment should start depends on how well the ovaries are responding to stimulation. Treatment with Ganirelix Gedeon Richter should be continued up to the day that there are enough large follicles (small sacs in the ovary that hold the eggs) to allow egg collection (harvesting).Ganirelix Gedeon Richter is preferably given into the upper leg. The patient or their partner may give the injections themselves if they have been trained and have access to expert advice.For more information about using Ganirelix Gedeon Richter, see the package leaflet or contact your doctor or pharmacist.

How does Ganirelix Gedeon Richter work?

During fertility treatment, ovarian stimulation with FSH or corifollitropin alfa is normally used to make the ovaries produce more than one mature egg. A few days later, a hormone called human chorionic gonadotrophin (hCG) is given to trigger ovulation (the release of eggs) and the mature eggs are harvested for use in techniques such as in-vitro fertilisation. In premature ovulation, the ovariesrelease eggs that may be immature and not suitable for these techniques. The active substance in Ganirelix Gedeon Richter, ganirelix, blocks the receptors for a natural hormone called gonadotrophinreleasing hormone (GnRH). GnRH controls the secretion of another hormone called luteinising hormone (LH), which causes ovulation. By blocking the effect of GnRH, Ganirelix Gedeon Richter stops the production of LH, and thereby prevents premature ovulation.

How has Ganirelix Gedeon Richter 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, Orgalutran, and do not need to be repeated for Ganirelix Gedeon Richter.As for every medicine, the company provided studies on the quality of Ganirelix Gedeon Richter. There was no need for 'bioequivalence' studies to investigate whether Ganirelix Gedeon Richter 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 Ganirelix Gedeon Richter is very similar to 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 Ganirelix Gedeon Richter?

Because Ganirelix Gedeon Richter 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 Ganirelix Gedeon Richter authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Ganirelix Gedeon Richter has been shown to have comparable quality and to be bioequivalent to Orgalutran. Therefore, the Agency's view was that, as for Orgalutran, the benefits of Ganirelix Gedeon Richter 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 Ganirelix Gedeon Richter?

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


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Gardasil


What is Gardasil?

Gardasil is a vaccine. It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18). It is available in vials or prefilled syringes.

What is Gardasil used for?

Gardasil is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):• precancerous lesions (growths) in the cervix, vulva or vagina and anus;• cervical and anal cancers;• genital warts.Gardasil is given according to official recommendations.The vaccine can only be obtained with a prescription.

How is Gardasil used?

For people aged nine to thirteen years, Gardasil can be given as two doses six months apart. If the second dose is given earlier than six months after the first dose, a third dose should always be given. For people aged fourteen or above, Gardasil is normally given according to a three-dose schedule withthe second dose given two months after the first and the third given four months after the second. These same three doses can also be used in individuals aged nine to thirteen years.There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.It is recommended that individuals who receive the first dose of Gardasil should complete the dosing regimen with Gardasil. The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.

How does Gardasil work?

Human papillomaviruses are viruses that cause warts and abnormal tissue growth. There are more than 100 types of papillomavirus, some of which are associated with genital cancers. HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers. HPV types 6 and 11 cause approximately 90% of genital warts.All papillomaviruses have a shell, or 'capsid', that is made up of proteins called 'L1 proteins'. Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as 'recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins. The proteins are assembled in 'virus-like particles' (structures that look like HPV, so that the body can recognise them easily). These virus-like particles are not capable of causing infection.When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins. After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses. This will help to protect against the diseases caused by these viruses.The vaccine also contains an 'adjuvant' (a compound containing aluminium) to stimulate a better response.

How has Gardasil been studied?

In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years. The studies looked at how many women developed genital lesions or warts that were due to HPV infection. The women were followed up for around three years after the third dose of the vaccine.Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.Another study in around 800 girls and women compared the effect of two doses of Gardasil in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years. The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18 one month after the last dose.Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.

What benefit has Gardasil shown during the studies?

In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18. In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types. A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina. In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group. The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31. In addition, these studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women. The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.The study testing Gardasil given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo. With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients). There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.

What is the risk associated with Gardasil?

In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling). For the full list of all side effects reported with Gardasil, see the package leaflet.Patients who show signs of an allergy after a dose of Gardasil should not receive further doses of the vaccine. Vaccination should be postponed in patients who are ill with a high fever. For the full list of all restrictions, see the package leaflet.

Why has Gardasil been approved?

The CHMP decided that Gardasil'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 Gardasil?

A risk management plan has been developed to ensure that Gardasil 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 Gardasil, including the appropriate precautions to be followed by healthcare professionals and patients.


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Gardasil 9


What is Gardasil 9 and what is it used for?

Gardasil 9 is a vaccine used in males and females from the age of nine years to protect against the following conditions caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58):• precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus;• genital warts.Gardasil 9 is given according to official recommendations. It contains purified proteins from the nine types of HPV listed above.

How is Gardasil 9 used?

Gardasil 9 is a suspension for injection available in vials or prefilled syringes. Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over. For a twodose schedule, the second dose should be given between five and thirteen months after the first dose. For a three-dose schedule, the second dose should be given two months after the first and the third given four months after the second. There should always be at least one month between the first andthe second doses, and at least three months between the second and the third, and all doses should be given within a year.It is recommended that individuals who receive the first dose of Gardasil 9 should complete the dosing regimen using this medicine. The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.The vaccine can only be obtained with a prescription.

How does Gardasil 9 work?

Human papillomaviruses are viruses that cause warts and abnormal tissue growth. There are more than 100 types of papillomavirus, some of which are associated with anogenital cancers in both men and women. Nearly 100% of cervical cancers are caused by HPV infection. In Europe, approximately 90% of anal cancers, 15% of vulvar cancers, 70% of vaginal cancers, and 30 to 40% of penile cancers are estimated to be caused by HPV infection. HPV types 16 and 18 cause a large majority of cervical and anal cancers, while HPV types 6 and 11 cause most of genital warts. A further 5 HPV types (31, 33, 45, 52, and 58) also carry a high risk for developing cancer (they cause around 20% of cervical cancers).All papillomaviruses have a shell, or 'capsid', that is made up of proteins called 'L1 proteins'. Gardasil 9 contains the purified L1 proteins for the nine HPV types above, produced by a method known as 'recombinant DNA technology'. The proteins are assembled in 'virus-like particles' (structures that look like HPV, so that the body can recognise them easily). These virus-like particles are not capable of causing infection or disease.When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins. After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses. This will help to protect against the diseases caused by these viruses.The vaccine also contains an 'adjuvant', a compound containing aluminium to stimulate a better response.

What benefits of Gardasil 9 have been shown in studies?

Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies.The first study looked at the effectiveness of Gardasil 9 in over 14,000 women aged between 16 and 26 years. The study looked at how many women given Gardasil 9 developed disease (growths or cancer) due to HPV infection caused by HPV types 31, 33, 45, 52 and 58 when compared with Gardasil vaccine (a previously approved vaccine which protects against types 6, 11, 16 and 18). This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil. This study also showed that antibody levels against types 6, 11, 16 and 18 were adequate to protect against these four types of HPV infection. The women were followed up for around three and a half years after the third dose of the vaccine.The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years. The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 one month after the third dose. The study showed that the vaccine stimulates the production of adequate levels of antibodies against HPV of all nine types in girls and boys aged between nine and 15 years when compared with women 16-26 years of age, for whom protection against disease was demonstrated in the first study.The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years. The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil.The fourth main study compared the levels of antibodies against all nine HPV types one month after the third dose in around 1,419 young men aged 16 to 26 with those in 1,101 women aged 16 to 26. This study found that Gardasil 9 stimulates similar levels of protection against all nine virus types in young men and women.The fifth main study involving 1,518 subjects compared the effect of a two-dose schedule of Gardasil 9 with a three-dose schedule. This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9.

What are the risks associated with Gardasil 9?

In studies, the most common side effects with Gardasil 9 (seen in more than 1 patient in 10) were reactions at the site of the injection (redness, pain and swelling) and headache. These side effects were normally mild or moderate. For the full list of all side effects reported with Gardasil 9, see the package leaflet.Patients who show signs of an allergy after a dose of Gardasil 9 (or of its precursor vaccines Gardasil or Silgard) should stop the vaccination course or should not receive Gardasil 9 at all. For the full list of all restrictions, see the package leaflet.

Why is Gardasil 9 approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil 9's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types. Thus Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV. Regarding side effects, although a large proportion of subjects develop injection site reactions, these are only slightly more than for Gardasil.

What measures are being taken to ensure the safe and effective use of Gardasil 9?

A risk management plan has been developed to ensure that Gardasil 9 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 Gardasil 9, 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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Gavreto


What is Gavreto and what is it used for?

Gavreto is a cancer medicine for treating adults with advanced non-small cell lung cancer caused by changes in a gene called RET (known as RET fusion-positive NSCLC) and who have not been treated with a RET inhibitor.Gavreto contains the active substance pralsetinib.

How is Gavreto used?

Gavreto is available as capsules. Patients are recommended to take 400 mg per day with a glass of water on an empty stomach. The medicine can only be obtained with a prescription.For more information about using Gavreto, see the package leaflet or contact your doctor or pharmacist.

How does Gavreto work?

The active substance in Gavreto, pralsetinib, is a RET inhibitor, which belongs to a broader class of cancer medicines known as tyrosine kinase inhibitors. It blocks the activity of an abnormal protein called RET fusion protein, which is made by the body due to a change in the RET gene. In NSCLC cells, RET fusion proteins can lead to uncontrolled cell growth and cancer. By blocking RET fusion proteins, pralsetinib helps to reduce the growth and spread of the cancer.

What benefits of Gavreto have been shown in studies?

In one main study, Gavreto was effective at reducing tumour size in patients with RET fusion-positive NSCLC who had not been treated before as well as in those previously treated with platinum-based chemotherapy. In the study, Gavreto was not compared with any other treatment or placebo (dummy treatment).Response to treatment was assessed using body scans, with a complete response being when the patient had no remaining signs of cancer. In previously untreated patients, around 72% (54 out of 75) responded completely or partially to treatment with Gavreto. In patients receiving Gavreto after beingtreated with platinum-based chemotherapy, around 59% (80 out of 136) responded completely or partially to treatment with Gavreto.

What are the risks associated with Gavreto?

The most common side effects with Gavreto (which may affect more than 3 in 10 people) are anaemia (low levels of red blood cells), neutropenia (low levels of neutrophils, a type of white blood cell), constipation, bone or muscle pain, tiredness, leukopenia (low levels of white blood cells), an increased amount of aminotransferases (liver enzymes), and increased blood pressure. The most common serious side effects are pneumonia (lung infections), pneumonitis (lung inflammation) and severe anaemia. Other common side effects include haemorrhage (bleeding) (more than 1 in 10 people) and QT prolongation (a change in the heart's electrical activity) (more than 1 in 100 people).For the full list of side effects and restrictions, see the package leaflet.

Why is Gavreto authorised in the EU?

One main study showed that Gavreto is effective at shrinking tumours in patients with RET fusionpositive NLCSC. Regarding safety, the side effects seen to date are considered manageable. Given the seriousness of the condition and the lack of existing treatments, the European Medicines Agency decided that Gavreto's benefits are greater than its risk and it can be authorised for use in the EU.Gavreto 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 European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Gavreto?

Since Gavreto has been given conditional authorisation, the company that markets Gavreto will submit further results from the ongoing main study for data on the long-term effectiveness and safety of Gavreto and provide results from another study that compares Gavreto with the current standard of care.

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

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


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Gazyvaro


What is Gazyvaro and what is it used for?

Gazyvaro is a cancer medicine used to treat adults with:• previously untreated chronic lymphocytic leukaemia (CLL). CLL is a cancer of B-lymphocytes, a type of white blood cell. Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended;• follicular lymphoma (FL), another type of cancer of B-lymphocytes. Gazyvaro is used together with chemotherapy (other cancer medicines) in patients who have not had previous treatment for advanced FL. It is also used with the medicine bendamustine in patients whose disease has not responded to treatment involving the medicine rituximab or whose cancer has progressed within 6 months after such treatment. Once the disease has responded to treatment, Gazyvaro is then used on its own for the maintenance treatment of FL.Gazyvaro contains the active substance obinutuzumab.These diseases are rare, and Gazyvaro 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 (CLL: 10 October 2012; FL: 19 June 2015).

How is Gazyvaro used?

Gazyvaro can only be obtained with a prescription and treatment should be given under the close supervision of an experienced doctor. As serious side effects including allergic reactions can develop, treatment should be given in facilities where these reactions can be treated promptly.Gazyvaro is given by infusion (drip) into a vein over several hours. It is given in six or eight cycles and each cycle lasts 21 or 28 days.The dosage schedule depends on what Gazyvaro is used for.Patients may also be given other medicines to prevent infusion-related reactions and other side effects. For more information about using Gazyvaro, see the package leaflet or contact your doctor or pharmacist.Send us a

How does Gazyvaro work?

The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD20, which is found on B-lymphocytes. In CLL and FL, cancerous B-lymphocytes multiply too quickly and replace normal cells in the bone marrow (where blood cells are made) and in lymph nodes. By attaching to CD20 on B-lymphocytes, obinutuzumab makes them a target for the body's immune (defence) system, which kills the B-lymphocytes.

What benefits of Gazyvaro have been shown in studies?

CLLIn CLL, Gazyvaro delayed the disease getting worse in previously untreated patients who had other medical conditions and were therefore ineligible for fludarabine-based therapy. In one main study involving 781 patients, those treated with Gazyvaro and chlorambucil lived longer without their disease getting worse than patients treated with chlorambucil alone (26.7 months on average versus 11.1 months). Similarly, patients treated with Gazyvaro and chlorambucil lived longer without their disease getting worse than patients treated with rituximab and chlorambucil (26.7 months versus 15.2months).FLGazyvaro was of benefit in one main study involving 1,202 patients with previously untreated FL. The study compared Gazyvaro plus other chemotherapy medicines with rituximab plus other chemotherapy medicines. Over a follow-up period of about 3 years on average, 17% (101 of 601 patients) given Gazyvaro died or their disease got worse, compared with 24% (144 of 601 patients) given rituximab.Gazyvaro has also been investigated in a study involving 321 patients with FL in whom treatment with rituximab had either not worked or had stopped working. Patients treated with Gazyvaro and bendamustine lived longer without their disease getting worse than patients treated with bendamustine alone (29.2 months on average versus 13.7 months).

What are the risks associated with Gazyvaro?

The most common side effects with Gazyvaro (which may affect more than 1 in 10 people) are upper respiratory infections (such as throat and nose infections), pneumonia (lung infection), urinary tract infections, inflammation in the nose and throat, sinusitis (inflammation of the sinuses), shingles, coughs, diarrhoea, constipation, joint and back pain, pain in arms and legs, headache, insomnia, hair loss, itching, fever, weakness, tiredness, neutropenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts) and reactions related to the infusion (which may include vomiting, dizziness, breathing difficulties, flushing, changes in blood pressure and rapid heart rate). For the full list of side effects and restrictions of Gazyvaro, see the package leaflet.

Why is Gazyvaro authorised in the EU?

The European Medicines Agency decided that Gazyvaro's benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated. The pattern of side effects was considered acceptable in the light of the medicine's benefit.

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

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


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Gefitinib Mylan


What is Gefitinib Mylan and what is it used for?

Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body). It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).Gefitinib Mylan contains the active substance gefitinib and is a 'generic medicine'. This means that Gefitinib Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Iressa. For more information on generic medicines, see the question-and-answer document here.

How is Gefitinib Mylan used?

Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments.Gefitinib Mylan is available as 250 mg tablets to be taken by mouth. The recommended dose is one tablet once a day. The tablet can be dispersed in water for patients who have difficulty swallowing.For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Gefitinib Mylan work?

The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor. This means that it blocks specific enzymes known as tyrosine kinases. These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells. EGFR is involved in the growth and spread of cancer cells. By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer. Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.

How has Gefitinib 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, Iressa, and do not need to be repeated for Gefitinib Mylan.As for every medicine, the company provided studies on the quality of Gefitinib 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 Gefitinib Mylan?

Because Gefitinib 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 Gefitinib Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa. Therefore, the Agency's view was that, as for Iressa, the benefit of Gefitinib 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 Gefitinib Mylan?

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


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Gencebok


What is Gencebok and what is it used for?

Gencebok is a stimulant medicine used for treating apnoea of prematurity, a condition in which babies born prematurely stop breathing for longer than 20 seconds.Gencebok contains the active substance caffeine citrate.Gencebok is a 'hybrid' medicine. This means that it is similar to a 'reference medicine' containing the same active substance, but at a different strength. The reference medicine for Gencebok is Peyona.

How is Gencebok used?

Gencebok can only be obtained with a prescription. A doctor with experience of treating newborn babies requiring intensive care should start treatment with the medicine. It should be given only in an intensive care unit for newborns that is well equipped to closely monitor the baby.The dose of Gencebok is calculated using the baby's weight. The first dose (of 20 mg caffeine citrate per kilogram of bodyweight) is given by infusion (drip) into a vein over 30 minutes, using a device to closely control the rate at which the medicine is given. To continue treatment, Gencebok is given in lower doses (5 mg caffeine citrate per kilogram of bodyweight) every 24 hours. These lower doses can be given either by infusion over 10 minutes or by mouth (e.g. through a tube into the stomach).Treatment usually continues until the baby can breathe well enough for at least 5 days.For more information about using Gencebok, see the package leaflet or contact your doctor or pharmacist.

How does Gencebok work?

Apnoea in premature babies occurs because the part of the baby's brain that controls breathing ('breathing centre') is not fully developed.Caffeine citrate, the active substance in Gencebok, blocks the effect of adenosine. Adenosine is a natural substance that slows down the activity of some parts of the brain including the breathing centre. By reducing the effect of adenosine, caffeine citrate stimulates the brain to restore breathing.Send

How has Gencebok 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, Peyona, and do not need to be repeated for Gencebok.As for every medicine, the company provided studies on the quality of Gencebok. There was no need for 'bioequivalence' studies to investigate whether Gencebok is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Gencebok is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.There was also no need for bioequivalence studies for Gencebok when used by mouth. This is because the composition of Gencebok is very similar to that of the reference medicine, except for the strength, and both are expected to be absorbed in the same way when given by mouth.

What are the benefits and risks of Gencebok?

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

Why is Gencebok authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Gencebok has been shown to be comparable to Peyona. Therefore, the Agency's view was that, as for Peyona, the benefits of Gencebok 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 Gencebok?

The company that markets Gencebok will provide a card to display in intensive care units where the medicine will be used. It will include information, warnings and precautions on the appropriate and safe use of Gencebok, including how to work out and prescribe the dose.Recommendations and precautions for the safe and effective use of Gencebok have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Gencebok are continuously monitored. Side effects reported with Gencebok are carefully evaluated and any necessary action taken to protect patients.


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Genvoya


What is Genvoya and what is it used for?

Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).It is used in adults and children from 2 years of age and weighing at least 14 kg whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

How is Genvoya used?

Genvoya can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.The medicine is available as tablets at two different strengths. The recommended dose, which depends on the patient's age and weight, is one tablet a day, taken with food.For more information about using Genvoya, see the package leaflet or contact your doctor or pharmacist.

How does Genvoya work?

Genvoya contains four active substances. Elvitegravir is a type of antiviral agent called an 'integrase inhibitor'. By blocking an enzyme called integrase, elvitegravir stops the virus' genetic material from integrating into the genetic material of the cells it has infected. This reduces the virus' ability to replicate and slows down the spread of infection. Cobicistat increases the level of elvitegravir by slowing its breakdown. This boosts elvitegravir's antiviral effect.Tenofovir alafenamide is a 'prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are related antiviral agents called reversetranscriptase inhibitors. They block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected. By blocking reverse transcriptase, Genvoya reduces the amount of HIV-1 in the blood and keeps it at a low level.Genvoya does not cure HIV-1 infection or AIDS, but it holds off damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Genvoya have been shown in studies?

Genvoya was investigated in two main studies involving 1,733 adults infected with HIV-1 who had not been treated previously. In both studies, Genvoya was compared with another antiviral medicine which contained the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. The main measure of effectiveness was the reduction of the amount of HIV-1 in the blood. The infection was considered to have responded to treatment if the viral load in the patient's blood was less than 50 copies of HIV-1 RNA/ml. After 48 weeks around 90% of patients treated with either Genvoya (800 of 866 patients) or the comparator (784 of 867 patients) had responded to treatment.In a supporting study, patients who were being treated with effective HIV treatment either continued with the same treatment or were switched to Genvoya. After 48 weeks a viral load of less than 50 copies/ml was seen in 97% (932 of 959) of patients switched to Genvoya and 93% (444 of 477) of patients who continued with their usual treatment.In another study, Genvoya was given to adolescents aged 12 to 18 years with HIV-1 infection who had not been treated previously. The viral load was reduced to less than 50 copies/ml after 24 weeks in 90% (45 of 50) of patients.This study also involved children below 12 years of age who were being treated with effective HIV treatment and who were switched to Genvoya. In 23 children aged 8 to 11 years weighing at least 25 kg, the viral load remained below 50 copies/ml after 48 weeks of treatment with Genvoya at the same dose as that used in adults. In children aged at least 2 years and weighing between 14 kg and less than 25 kg, the viral load remained below 50 copies/ml in 96% (26 of 27) of patients after 48 weeks of treatment with Genvoya at a lower dose than that used in adults.

What are the risks associated with Genvoya?

The most common side effect with Genvoya (which may affect more than 1 in 10 people) is nausea (feeling sick). Other side effects include headache and diarrhoea. For the full list of side effects reported with Genvoya, see the package leaflet.Genvoya must not be taken with certain other medicines because of the possibility of harmful interactions. For the full list of restrictions, see the package leaflet.

Why is Genvoya authorised in the EU?

In studies, the effectiveness of Genvoya was high in patients aged at least 2 years of age, and in adults it was comparable to that of a medicine containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.Three of the active substances, elvitegravir, cobicistat and emtricitabine, have already been shown to be effective. The fourth, tenofovir alafenamide, is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects. The European Medicines Agency also considered that combining the medicines in a single tablet simplifies treatment.Genvoya's side effects were similar to those of the individual active substances. In adults, tenofovir alafenamide had a milder effect on the kidney than tenofovir disoproxil. A possible risk of bone density loss in young children given tenofovir alafenamide could be minimised with regular monitoring during treatment.The Agency therefore decided that Genvoya'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 Genvoya?

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


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Ghryvelin


What is Macimorelin Aeterna Zentaris and what is it used for?

Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone. It is used by doctors to diagnose growth hormone deficiency, a condition where the patient does not have enough growth hormone. It is not used to treat patients with the condition.Macimorelin Aeterna Zentaris contains the active substance macimorelin.

How is Macimorelin Aeterna Zentaris used?

Macimorelin Aeterna Zentaris is available as granules that are dissolved in water and taken by mouth. The recommended dose is 0.5 mg per kg body weight which the patient should take once. The doctor then takes blood samples 45, 60 and 90 minutes later to see how much growth hormone the body has produced.Macimorelin Aeterna Zentaris can only be obtained with a prescription and its use must be supervised by a healthcare professional experienced in diagnosing growth hormone deficiency. For more information about using Macimorelin Aeterna Zentaris, see the package leaflet or contact your doctor or pharmacist.

How does Macimorelin Aeterna Zentaris work?

The active substance in Macimorelin Aeterna Zentaris, macimorelin, stimulates the release of growth hormone into the blood by activating receptors (targets) found on cells in the pituitary gland, a gland located at the base of the brain. The level of growth hormone in the blood is then measured and indicates whether or not the body is able to produce growth hormone.

What benefits of Macimorelin Aeterna Zentaris have been shown in studies?

Macimorelin Aeterna Zentaris was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.The study involved 166 adults who had either a high, intermediate or low likelihood of having growth hormone deficiency, or who were confirmed not to have growth hormone deficiency. Among them, 140 were tested with both Macimorelin Aeterna Zentaris and ITT.Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with Macimorelin Aeterna Zentaris; 74% of people who tested positive with ITT also tested positive with Macimorelin Aeterna Zentaris. This means that, although Macimorelin Aeterna Zentaris might not diagnose all cases of disease, it can help to confirm presence of the disease.

What are the risks associated with Macimorelin Aeterna Zentaris?

The most common side effects with Macimorelin Aeterna Zentaris (which may affect up to 1 in 10 people) are a bitter or metallic taste, tiredness, headache, nausea (feeling sick), dizziness, diarrhoea and feeling hot. Macimorelin Aeterna Zentaris may also cause a change in heart rhythm. Overall, the side effects were mostly mild and short-lasting, with no need for a specific treatment.For the full list of side effects and restrictions with Macimorelin Aeterna Zentaris, see the package leaflet.

Why is Macimorelin Aeterna Zentaris authorised in the EU?

Macimorelin Aeterna Zentaris gave a similar number of negative test results for growth hormone deficiency as a comparator test; however, it gives fewer positive test results than the comparator. EMA considered that it is a priority to avoid over-diagnosis of adult growth hormone deficiency and that Macimorelin Aeterna Zentaris helps confirm positive diagnosis and so avoid unnecessary treatment of patients with a false positive test result.In terms of safety, the main concern was that the medicine may change heart rhythm. However this risk is considered small as patients take only one dose of the medicine and are supervised by their doctor. On the whole, Macimorelin Aeterna Zentaris has fewer side effects than the comparator test, which temporarily lowers the level of sugar in the blood.EMA therefore decided that Macimorelin Aeterna Zentaris'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 Macimorelin Aeterna Zentaris?

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


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Giapreza


What is Giapreza and what is it used for?

Giapreza is a medicine used in adults with dangerously low blood pressure (a condition known as shock).It is used when other treatments for raising blood pressure have not worked and contains the active substance angiotensin II.

How is Giapreza used?

The medicine should be prescribed by a physician experienced in the treatment of shock and is for use in a hospital setting. It is given as a continuous infusion ('drip') into a vein. The dose depends on the patient's weight and should be adjusted according to the patient's blood pressure.For more information about using Giapreza, see the package leaflet or contact your doctor or pharmacist.

How does Giapreza work?

The active substance in Giapreza, angiotensin II, is the same as a hormone that the body produces. Angiotensin II increases blood pressure by narrowing blood vessels and releasing another hormone (aldosterone) that increases the volume of blood circulating in the body.

What benefits of Giapreza have been shown in studies?

A main study involving 344 patients in shock has shown that Giapreza is effective at raising blood pressure when other treatments have not worked. After 3 hours, 70% of patients treated with Giapreza in addition to standard treatments had their average arterial blood pressure rise to above 75 mmHg (an acceptable level) or by at least 10 mmHg, compared with 23% of patients treated with placebo (a dummy treatment) and standard treatments.

What are the risks associated with Giapreza?

The most common side effects with Giapreza (which may affect more than 1 in 10 people) are thromboembolic events (problems due to clots in blood vessels) and short-lived high blood pressure.For the full list of side effects and restrictions with Giapreza, see the package leaflet.

Why is Giapreza authorised in the EU?

The main study showed that adding Giapreza to standard treatment was effective in increasing average blood pressure in patients in shock. The rise in blood pressure is expected to help prevent organ damage and reduce the number of deaths from this condition. The side effects of Giapreza were similar to those of standard treatments and were considered manageable. The European Medicines Agency therefore decided that Giapreza'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 Giapreza?

The company that markets Giapreza will carry out a study to further investigate the effectiveness and safety of Giapreza, including whether the medicine could prevent damage to organs and affect how long patients live.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Giapreza have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Giapreza are continuously monitored. Side effects reported with Giapreza are carefully evaluated and any necessary action taken to protect patients.


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Gilenya


What is Gilenya and what is it used for?

Gilenya is a type of medicine known as a 'disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. 'Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.Gilenya contains the active substance fingolimod.

How is Gilenya used?

Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Gilenya is available as capsules (0.25 mg and 0.5 mg). The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight.Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption. Details on the recommendations for monitoring patients are found in the summary of product characteristics.For more information about using Gilenya, see the package leaflet or contact your doctor or pharmacist.

How does Gilenya work?

In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord. The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1phosphate receptor, which is involved in controlling the movement of these cells in the body.

What benefits of Gilenya have been shown in studies?

Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis. The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year.In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years. Patients treated with Gilenya had around half the number of relapses compared with patients given placebo.In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year. Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years. Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a.

What are the risks associated with Gilenya?

The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems). The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment. For the full list of side effects of Gilenya, see the package leaflet.Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems. Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain. Women should not become pregnant while taking Gilenya and for two months after treatment has stopped. For the full list of restrictions, see the package leaflet.

Why is Gilenya authorised in the EU?

The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis in both adults and children and noted that it had the benefit of being taken by mouth while most other medicines for this disease are given by injection. However, because of possible side effects, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly. In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose. The Agency decided that Gilenya'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 Gilenya?

The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation. It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya. The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Gilenya are continuously monitored. Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients.


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Giotrif


What is Giotrif and what is it used for?

Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer. It is used specifically in adults with advanced cancer in the following situations:• when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.• when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.Giotrif contains the active substance afatinib.

How is Giotrif used?

Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription. The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.The tablets should be taken without food and no food should be eaten for at least 3 hours before and 1 hour after taking the tablets.

How does Giotrif work?

The active substance in Giotrif, afatinib, is an ErbB family blocker. This means that it blocks the action of a group of proteins known as 'ErbB family' which are found on the surface of cancer cells and are involved in stimulating the cells to divide. By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.EGFR proteins are part of the ErbB family. Lung cancer cells with mutated EGFR proteins are particularly sensitive to afatinib.

What benefits of Giotrif have been shown in studies?

Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.

What are the risks associated with Giotrif?

The most common side effects with Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), reduced appetite, epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), rash, acneiform dermatitis (acne-like skin conditions), pruritus (itching), and dry skin. For the full list of all side effects and restrictions with Giotrif, see the package leaflet.

Why is Giotrif approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits ofGiotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU. The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients. In addition, the side effects of the medicine were considered to be manageable and similar to those seen with medicines of the same class.

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

A risk management plan has been developed to ensure that Giotrif 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 Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.


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Givlaari


What is Givlaari and what is it used for?

Givlaari is a medicine for treating acute hepatic porphyria in patients aged 12 years or over.Acute hepatic porphyria is a rare genetic condition in which the liver cannot properly produce a substance called haem. As a result, substances used to make haem build up in the body, causing attacks of severe abdominal pain, vomiting and nervous system disorders.Acute hepatic porphyria is rare, and Givlaari was designated an 'orphan medicine' (a medicine used in rare diseases) on 29 August 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3161731.Givlaari contains the active substance givosiran.

How is Givlaari used?

Givlaari is given by injection under the skin once a month. The dose depends on the patient's weight.The medicine can only be obtained with a prescription and treatment should be started by a healthcare professional experienced in managing the condition. For more information about using Givlaari, see the package leaflet or contact your doctor or pharmacist.

How does Givlaari work?

The active substance in Givlaari, givosiran, is a synthetic small interfering RNA (a type of genetic material) that works by reducing the production of an enzyme involved in an early step of haem production in the liver. This prevents the build-up of the substances that cause the symptoms of the condition.

What benefits of Givlaari have been shown in studies?

Givlaari was more effective than placebo (a dummy treatment) in reducing the yearly number of serious porphyria attacks. In a main study involving 94 patients, those who received Givlaari had on average 3 serious attacks of symptoms per year compared with 13 in those receiving placebo.

What are the risks associated with Givlaari?

The most common side effects with Givlaari (which may affect more than 1 in 5 people) are reactions at the site of the injection, nausea (feeling sick) and tiredness. For the full list of side effects and restrictions, see the package leaflet.

Why is Givlaari authorised in the EU?

A main study has shown that Givlaari is effective at reducing porphyria attacks. The side effects of Givlaari treatment were mostly mild and moderate and most resolved during the study.The European Medicines Agency therefore decided that Givlaari'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 Givlaari?

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


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Gliolan


What is Gliolan?

Gliolan is a powder to be made up into a solution to be taken by mouth. It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).

What is Gliolan used for?

Gliolan is used in adult patients with malignant glioma (a type of brain tumour). Gliolan helps surgeons to see the tumour more clearly during an operation to remove it from the brain.Because the number of patients with malignant glioma is low, the disease is considered 'rare', and Gliolan was designated an 'orphan medicine' (a medicine used in rare diseases) on 13 November 2002.The medicine can only be obtained with a prescription.

How is Gliolan used?

Gliolan should only be used by experienced brain surgeons who are familiar with surgery of malignant glioma, who have an in-depth knowledge of the anatomy of the brain, and who have completed a training course in surgery guided by fluorescence.The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised. Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution. Gliolan should be used with caution in patients who have problems with their liver or kidneys.

How does Gliolan work?

The active substance in Gliolan, 5-aminolevulinic acid, is a 'sensitiser used in photodynamic therapy'. It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX). Since glioma cells take up more of the active substance and convert it more rapidly into PPIX, higher levels of PPIX accumulate in the cancer cells than in normal tissue. When illuminated under blue light of a specific wavelength, the PPIX in the tumour glows an intense red, while the normal brain tissue appears blue. This enables the surgeon to see the tumour more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue.(c)EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

How has Gliolan been studied?

The effects of Gliolan were first tested in experimental models before being studied in humans. However, because 5-aminolevulinic acid is a naturally occurring substance which is already used in some other conditions, the company also presented data from the published literature.Gliolan has been studied in one main study involving 415 patients with malignant glioma who were about to undergo brain surgery to remove the tumour. The outcome of the operation was compared between patients taking Gliolan (operated under blue light) and that of patients who did not take any medicines to improve the visibility of the tumour (operated under normal white light). The main measures of effectiveness were the proportion of patients who had no visible tumour on a brain scan taken 72 hours after the operation, and the proportion who survived six months without the brain tumour coming back or getting bigger ('progressing'). The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.

What benefit has Gliolan shown during the studies?

Removal of the brain tumour during surgery was more complete when Gliolan was used. At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan. After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.

What is the risk associated with Gliolan?

The most common side effects seen with Gliolan are due to a combination of the medicine itself, as well as anaesthesia and the removal of the tumour. The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase). For the full list of all side effects reported with Gliolan, see the Package Leaflet.Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins. It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.

Why has Gliolan been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that surgical treatment for malignant glioma should aim to remove as much of the tumour as possible while sparing healthy brain tissue. It concluded that Gliolan increases the ability of the tumour to be distinguished from healthy brain tissue during surgery, and that it increases the proportion of patients whose tumours are completely removed and extends the time that patients survive without progression.The Committee decided that Gliolan's benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma. It recommended that Gliolan be given marketing authorisation.

Which measures are being taken to ensure the safe use of Gliolan?

Before the medicine is launched, the company that makes Gliolan will set up training courses in all Member States for brain surgeons to inform them about how to use the medicine safely and effectively during surgery.


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Glivec


What is Glivec?

Glivec is a medicine that contains the active substance imatinib. It is available as capsules (50 and 100 mg) and tablets (100 and 400 mg).

What is Glivec used for?

Glivec is an anticancer medicine. It is used to treat the following diseases:• chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control. Glivec is used when the patients are 'Philadelphia chromosome positive' (Ph+). This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome. Glivec is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant. It is also used in adults and children in the 'chronic phase' of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease ('accelerated phase' and 'blast crisis');• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. Glivec is used in combination with other anticancer medicines in adults and children who have been newly diagnosed with Ph+ ALL. It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or is not responding to other medicines.• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Glivec is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control. Glivec is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRa;• gastrointestinal stromal tumours (GIST), a type of cancer (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs. Glivec is used to treat adults with GIST that cannot be removed with surgery or have spread to other parts of the body, and adults who are at risk of GIST coming back after surgical removal;• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Glivec is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.The medicine can only be obtained with a prescription.

How is Glivec used?

Glivec treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours. Glivec is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut. The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day. For more information, see the package leaflet.

How does Glivec work?

The active substance in Glivec, imatinib, is a protein-tyrosine kinase inhibitor. This means that it blocks some specific enzymes known as tyrosine kinases. These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. By blocking these receptors, Glivec helps to control cell division.

How has Glivec been studied?

For CML, Glivec has been examined in four main studies involving 2,133 adults and one study of 54 children. These included a study involving 1,106 adults that compared Glivec with the combination of interferon alpha plus cytarabine (other anticancer medicines). This study measured how long the patients lived without their cancer getting worse.For Ph+ ALL, Glivec has been examined in three studies involving 456 adults, including one study comparing Glivec with standard chemotherapy (medicines used to kill cancer cells) in 55 newly diagnosed patients. It has also been examined in a fourth main study involving 160 children and young people aged 1 to 22 years.For GIST, Glivec has been examined in two main studies. One involved 147 patients whose GIST could not be surgically removed or had spread to other parts of the body, and looked at whether the tumours shrank in size. This study did not compare Glivec with any other medicines. The other study compared Glivec with placebo (a dummy treatment) in 713 patients whose cancer had been removed with surgery. This study measured how long the patients lived without their cancer coming back.For MD/MPD (31 patients), HES and CEL (176 patients), and DFSP (18 patients), Glivec was not compared with any other medicines. These studies examined whether blood cell counts returned to normal levels, or whether the number of cancerous blood cells or the size of tumours fell.

What benefit has Glivec shown during the studies?

Glivec was more effective than the comparator medicines. In patients with CML, the cancer had got worse in 16% of the patients taking Glivec after five years, compared with 28% of those taking interferon alpha plus cytarabine. Glivec was also better than standard chemotherapy in patients with Ph+ ALL. In patients with GIST that had been removed with surgery, patients taking Glivec lived for longer than those taking placebo without their cancer coming back. In the non-comparative studies of CML, Ph+ ALL and GIST, between 26 and 96% of patients showed a response to Glivec. In the study of patients aged 1 to 22 years who had Ph+ ALL, Glivec was shown to increase how long the patients lived without any major events (such as a relapse).Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec.

What is the risk associated with Glivec?

The most common side effects with Glivec (seen in more than 1 in 10 patients) are weight increase, neutropenia (low levels of the white blood cells that fight infection), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, periorbital oedema (swelling around the eyes), rash, muscle spasm and cramps, muscle, bone and joint pain, fluid retention and fatigue (tiredness). For the full list of all side effects reported with Glivec, see the package leaflet.Glivec must not be used in people who are hypersensitive (allergic) to imatinib or any of the other ingredients.

Why has Glivec been approved?

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


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Glyxambi


What is Glyxambi and what is it used for?

Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels. It contains two active substances, empagliflozin and linagliptin.Glyxambi is used in the following groups:• patients whose blood glucose levels are not controlled well enough by a combination of one ofGlyxambi's active substances (empagliflozin or linagliptin) with other diabetes medicines (metformin and/or a sulphonylurea);• patients who are already taking empagliflozin and linagliptin as separate tablets.

How is Glyxambi used?

Glyxambi is available as tablets containing 10 or 25 mg of empagliflozin with 5 mg of linagliptin, and can only be obtained with a prescription. The recommended dose is one tablet once a day. Patients switching from empagliflozin and linagliptin to Glyxambi should receive the strength of Glyxambi that corresponds to the doses of empagliflozin and linagliptin in the separate tablets they were taking.If Glyxambi is used in combination with insulin or a sulphonylurea, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels). The doctor may need to reduce theSenddose of Glyxambi or discontinue its use in patients with reduced kidney function. For further information, see the package leaflet.

How does Glyxambi work?

Type 2 diabetes is a disease in which the body 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 result is a high level of glucose in the blood. The two active substances in Glyxambi work in different ways to lower glucose levels:• Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). Normally, as blood is filtered by the kidneys, SGLT2 stops glucose in the blood from being passed out into the urine. By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood.Empagliflozin has been authorised in the European Union (EU) as Jardiance since 2014.• Linagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Linagliptin has been authorised in the EU as Trajenta since 2011.Together, these actions reduce blood glucose levels and help to control type 2 diabetes.

What benefits of Glyxambi have been shown in studies?

Empagliflozin in combination with linagliptin (the same combination as in Glyxambi) was evaluated in 3 main studies involving 1,221 adults with type 2 diabetes. The main measure of effectiveness was the change after 24 weeks of treatment in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin and linagliptin. Patients were then given either empagliflozin or placebo (a dummy treatment) in addition to their existing treatment. Results showed that when empagliflozin was added to linagliptin and metformin, HbA1c levels decreased by 0.7-0.8 percentage points after 24 weeks, compared with no reduction when placebo was added. HbA1c levels were just below 8% at the start of the study.The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and empagliflozin. Adding linagliptin to treatment with empagliflozin and metformin for 24 weeks reduced HbA1c levels from 7.8% to 7.2%, compared with a reduction from 7.9% to 7.7% when placebo was added.A further study compared a fixed dose combination of empagliflozin and linagliptin (given in addition to metformin) with treatment with metformin plus either empagliflozin or linagliptin in patients who were not sufficiently controlled with metformin alone. The HbA1c levels were around 8% before treatment. After 24 weeks treatment the fixed dose combination reduced HbA1c levels to under 6.9% whereas they were around 7.3% with empagliflozin and linagliptin used alone.

What are the risks associated with Glyxambi?

The most common side effects with Glyxambi (which may affect more than 7 in 100 people) are urinary infections. The most serious side effects are ketoacidosis (high blood levels of acids called 'ketoacids'), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels). For the full list of all side effects reported with Glyxambi, see the package leaflet.Glyxambi must not be used in people who are hypersensitive (allergic) to empagliflozin, linagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor. For the full list of restrictions, see the package leaflet.

Why is Glyxambi approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Glyxambi's benefits are greater than its risks and recommended that it be approved for use in the EU.The CHMP considered that Glyxambi is effective at controlling blood glucose levels, with both components contributing to the effect. Regarding its safety profile, Glyxambi was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.

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

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


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Gonal-F


What is GONAL-f?

GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.

What is GONAL-f used for?

GONAL-f is used to treat the following groups:• adult women (aged 18 years or over) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);• adult women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation. GONAL-f is given to stimulate the ovaries to produce more than one egg at a time;• adult women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). GONAL-f is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;• adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). GONAL-f is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.The medicine can only be obtained with a prescription.

How is GONAL-f used?

Treatment with GONAL-f should be carried out by a doctor who has experience in the treatment of fertility problems.GONAL-f is given by injection under the skin once a day. If the powder is being used, it should be mixed with the solvent provided just before use. The dose of GONAL-f and how often it is given depend on why it is being used and on the patient's response to treatment. After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.For more information, see the package leaflet.

How does GONAL-f work?

The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH. In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles.Previously, the FSH used in medicines was extracted from urine. The follitropin alfa in GONAL-f is produced by a method known as 'recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.

How has GONAL-f been studied?

GONAL-f has been studied in 222 women who do not produce eggs or respond to clomiphene citrate. It has also been studied as part of assisted reproductive techniques in 470 women. In these studies, GONAL-f was compared with human FSH that had been extracted from urine.GONAL-f, in combination with LH, has also been studied in 38 women with severe LH and FSH deficiency, and in combination with hCG in 19 men with hypogonadotrophic hypogonadism. Because these conditions are rare, GONAL-f was not compared with any other treatments in these studies, and the low number of patients in the studies was considered to be acceptable.In the studies of women, the main measures of effectiveness were the number of eggs collected, the number of women who released eggs and the number of follicles produced in the ovaries (small sacs that hold the eggs). In men, the studies looked at the number of men who started to produce sperm within the first 18 months of treatment.

What benefit has GONAL-f shown during the studies?

GONAL-f was as effective as human FSH in women who did not produce eggs or respond to clomiphene citrate: 84% of the women receiving GONAL-f produced eggs, compared with 91% of those receiving human FSH. GONAL-f was also as effective as human FSH at stimulating the ovaries during assisted reproductive techniques.GONAL-f was effective in triggering egg development in women with severe LH and FSH deficiency. In the study in men, GONAL-f, used in combination with hCG, was effective in stimulating sperm production, with 63% of the men starting to produce sperm.

What is the risk associated with GONAL-f?

The most common side effects with GONAL-f (seen in more than 1 patient in 10) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluidwithin the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with GONAL-f, see the package leaflet.GONAL-f should not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary. It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons. In women, GONAL-f must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina. For the full list of restrictions, see the package leaflet.In some women, the ovaries can over-respond to stimulation. This is called 'ovarian hyperstimulation syndrome'. Doctors and patients must be aware of this possibility.

Why has GONAL-f been approved?

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


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Granpidam


What is Granpidam and what is it used for?

Granpidam is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries in the lungs). In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.Granpidam contains the active substance sildenafil. It is a 'generic medicine'. This means that Granpidam is similar to a 'reference medicine' already authorised in the European Union (EU) called Revatio. For more information on generic medicines, see the question-and-answer document here.

How is Granpidam used?

Granpidam can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.Granpidam is available as tablets (20 mg). In adults, Granpidam is taken at a dose of 20 mg three times a day. Lower doses of Granpidam may be needed in patients taking some medicines that affect the way Granpidam is broken down in the body.In children aged 1 to 17 years, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used. In children weighing less than 20 kg the maximum recommendeddose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given. For lower doses, other medicines containing sildenafil should therefore be used.

How does Granpidam work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs. This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. The active substance in Granpidam, sildenafil, 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 it is blocked, a substance called 'cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels. In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.

How has Granpidam been studied?

Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. In this case Granpidam was not compared with the reference product Revatio, but with Viagra. This was considered acceptable since Revatio and Viagra have the same composition and are made in the same way by the same manufacturer.

What are the benefits and risks of Granpidam?

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

Why is Granpidam approved?

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

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

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


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Granupas


What is Granupas and what is it used for?

Granupas is a tuberculosis medicine that contains the active substance para-aminosalicylic acid (PAS). It is used in combination with other medicines to treat adults and children from 28 days of age who have multi-drug resistant tuberculosis when combinations without this medicine cannot be used, either because the disease is resistant to them or because of their side effects.Multi-drug resistance is when the bacteria causing tuberculosis (Mycobacterium tuberculosis) are resistant to treatment with at least isoniazid and rifampicin, two standard tuberculosis medicines.Because the number of patients with tuberculosis is low in the EU, the disease is considered 'rare', and Granupas was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 December 2010.

How is Granupas used?

Granupas can only be obtained with a prescription. It is available as 4 g sachets containing 'gastroresistant' granules that allow the active substance to reach the intestine without being released in the stomach, thus reducing side effects in the stomach.1 Previously known as Para-aminosalicylic acid LucaneThe recommended dose for adults is one sachet three times a day. Treatment is usually continued for 2 years.In children and adolescents, the daily dose depends on their weight. They should be given a total of 150 mg per kilogram body weight every day, split into two doses. A dosing spoon is used to measure small doses for young children.

How does Granupas work?

The active substance, PAS, is a 'bacteriostatic agent', which means that it works by stopping the growth of M. tuberculosis bacteria. PAS is similar to a chemical (para-aminobenzoic acid) that is used by the bacteria to make folic acid needed for new bacteria to grow. By interfering and taking the place of this chemical in the processes that make folic acid, para-aminosalicylic acid reduces the amount of folic acid produced and thereby stops or slows the growth of M. tuberculosis.

What benefits of Granupas have been shown in studies?

PAS has been used for many years in the EU for the combination treatment of tuberculosis. The benefits in combination with other tuberculosis treatments were shown in published studies presented by the company, two of which were considered to be the main studies for the application.The first of these involved 166 patients with tuberculosis aged between 15 to 30 years. The patients were treated for 3 months with either PAS or another medicine called streptomycin, or with a combination of PAS and streptomycin, and then followed up for 3 extra months. At the end of the 6 months, 87% of patients on the combination had improvements in their chest x-rays compared with 56% of patients in the group taking PAS alone. In addition,33% of patients in the combination group had no bacteria detected in their phlegm (sputum) compared with 8% in the PAS group. PAS in combination with streptomycin also helped reduce the emergence of resistance to streptomycin: in 89% of patients receiving the combination the bacteria remained responsive to streptomycin, compared with 21% of patients who were given only streptomycin.In the second main study involving 341 patients aged over 12 years, PAS in combination with isoniazid was compared with isoniazid alone. After 12 months, 90% of patients in the combination group did not have the bacteria in their phlegm compared with 51% of patients given a comparable dose of isoniazid alone. In addition, the PAS-isoniazid combination helped reduce the emergence of resistance to isoniazid: after 1 year, while 47% of patients in the isoniazid-only group had resistant bacteria the figure was only 8% in the combination group.The applicant also provided published data on the doses of PAS to be used in children.

What are the risks associated with Granupas?

The most common side effects with Granupas (which may affect up to 1 in 10 people) are abdominal pain (stomach ache), vomiting, nausea, bloating, diarrhoea and soft stools, giddiness, disturbance in gait and balance, and allergic skin reactions and rash. For the full list of all side effects reported with Granupas, see the package leaflet.Granupas must not be taken by patients with severely reduced kidney function. For the full list of restrictions, see the package leaflet.

Why is Granupas approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Granupas's benefits are greater than its risks and recommended that it be approved for use in the EU.The Committee noted that the active substance, PAS, has been shown to be beneficial when used in combination with other medicines to treat tuberculosis and that it helps reduce the emergence of resistance to other medicines.PAS had been widely used in the past for combination treatment but was largely discontinued due to adverse effects on the stomach. The CHMP noted that Granupas contains gastro-resistant granules, designed to allow PAS to reach the intestine without being released in the stomach, and thus reduce the potential for side effects.The Committee also noted that the World Health Organization continues to recommend PAS as an option to be used in combination with other medicines for treating multi-drug resistant tuberculosis.

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

A risk management plan has been developed to ensure that Granupas 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 Granupas, including the appropriate precautions to be followed by healthcare professionals and patients.


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Grastofil


What is Grastofil and what is it used for?

Grastofil is a medicine that stimulates the production of white blood cells and is used:• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes). Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections;• 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.Grastofil is a 'biosimilar medicine'. This means that Grastofil is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Grastofil is Neupogen. For more information on biosimilar medicines, see here.

How is Grastofil used?

Grastofil can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment. The medicine is available in prefilled syringes and is given by injection under the skin or infusion (drip) into a vein.The way Grastofil 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. For more information about using Grastofil, see the package leaflet or contact your doctor or pharmacist.

How does Grastofil work?

The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.

What benefits of Grastofil have been shown in studies?

Grastofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy (medicines to treat cancer) known to cause neutropenia. Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Grastofil 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 which compared with 1.6 days and 1.8 days reported in studies using filgrastim found in the literature. Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.Studies were also carried out to show that Grastofil produces levels of the active substance in the body that are comparable to the reference medicine, Neupogen.

What are the risks associated with Grastofil?

The most common side effects with Grastofil (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Grastofil is being used for. For the full list of side effects and restrictions with Grastofil, see the package leaflet.

Why is Grastofil approved?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grastofil has been shown to have a comparable quality, safety and effectiveness to Neupogen. Therefore, the Agency's view was that, as for Neupogen, the benefits of Grastofil 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 Grastofil?

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


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Grasustek


What is Grasustek and what is it used for?

Grasustek is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection).Grasustek is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).Grasustek is a 'biosimilar medicine'. This means that Grasustek is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Grasustek is Neulasta. For more information on biosimilar medicines, see here.Grasustek contains the active substance pegfilgrastim.

How is Grasustek used?

Grasustek can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders. It is available as a prefilled syringe containing a solution for injection under the skin. Grasustek is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of cancer treatment. Patients can inject themselves if they have been trained appropriately.For more information about using Grasustek, see the package leaflet or contact your doctor or pharmacist.

How does Grasustek work?

The active substance in Grasustek, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF). Filgrastim works by encouragingthe bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.Filgrastim has been available in other medicines in the EU for a number of years. In Grasustek, filgrastim has been 'pegylated' (attached to a chemical called polyethylene glycol). This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.

What benefits of Grasustek have been shown in studies?

Laboratory studies comparing Grasustek with Neulasta have shown that the active substance inGrasustek is highly similar to that in Neulasta in terms of structure, purity and biological activity. Studies have also shown that giving Grasustek produces similar levels of the active substance in the body to giving Neulasta.In addition, a study involving 248 patients who had chemotherapy after surgery for breast cancer showed that Grasustek was as effective as Neulasta in reducing the duration of neutropenia. Severe neutropenia lasted just over one-and-a-half days on average with both medicines.Because Grasustek is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Grasustek.

What are the risks associated with Grasustek?

The safety of Grasustek 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 Neulasta. The most common side effect with Grasustek (which may affect more than 1 in 10 people) is pain in the bones. Pain in muscles is also common. For the full list of side effects and restrictions with Grasustek, see the package leaflet.

Why is Grasustek authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grasustek has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Grasustek in reducing the duration of neutropenia is equivalent to that of Neulasta.All these data were considered sufficient to conclude that Grasustek will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Neulasta, the benefits of Grasustek 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 Grasustek?

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


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Grepid


What is Grepid?

Grepid is a medicine that contains the active substance clopidogrel. It is available as pink tablets (75 mg).Grepid is a 'generic medicine'. This means that Grepid is similar to a 'reference medicine' already authorised in the European Union (EU) called Plavix. For more information on generic medicines, see the question-and-answer document here.

What is Grepid used for?

Grepid is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Grepid can be given to the following groups of patients:• patients who have recently had a myocardial infarction (heart attack). Grepid can be started between a few days and 35 days after the attack;• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Grepid can be started between seven days and six months after the stroke;• patients with peripheral arterial disease (problems with blood flow in the arteries). The medicine can only be obtained with a prescription.

How is Grepid used?

The standard dose of Grepid is one 75 mg tablet once a day, taken with or without food.

How does Grepid work?

The active substance in Grepid, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming 'sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.

How has Grepid been studied?

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

What are the benefit and risk of Grepid?

Because Grepid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Grepid been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Grepid has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Grepid be given marketing authorisation.


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