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.

Tabrecta


What is Tabrecta and what is it used for?

Tabrecta is a medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the cancer is advanced and its cells have particular genetic mutations (changes) leading to 'mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping'. This means that the cancer cells make an abnormal form of a protein called MET, because a part of the MET gene known as exon 14 is not used.Tabrecta is used when the patient needs further treatment after receiving immunotherapy or platinumbased chemotherapy, or both.Tabrecta contains the active substance capmatinib.

How is Tabrecta used?

Tabrecta can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in using cancer medicines.Before starting treatment, the patients should have tests to confirm the METex14 skipping mutations in their cancer.Tabrecta is available as tablets to be taken by mouth. The recommended dose is 400 mg twice per day. Treatment with Tabrecta can continue for as long as the patient benefits from it. If certain side effects develop, the doctor may decide to reduce the dose, or to interrupt or stop treatment with Tabrecta.For more information about using Tabrecta, see the package leaflet or contact your doctor or pharmacist.

How does Tabrecta work?

The MET protein belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells. In NSCLC patients with 'METex14 skipping', an abnormal form of the MET protein is produced that causes cancer cells to divide and grow in an uncontrolled fashion.The active substance in Tabrecta, capmatinib, is a receptor tyrosine kinase inhibitor that attaches to this abnormal MET protein inside cancer cells. This stops the effect of MET, helping to slow down the growth and spread of the cancer.

What benefits of Tabrecta have been shown in studies?

The effect of Tabrecta was investigated in a main study involving 100 patients with advanced NSCLC with a 'METex14 skipping' mutation and whose disease had progressed after previously being treated with immunotherapy with or without platinum-based chemotherapy. Response to treatment (shrinkage in the size of the cancer) was assessed using body scans and 44% of the patients showed partial or complete cancer shrinkage after being treated with Tabrecta. On average, the response lasted for at least 10 months.In this study, Tabrecta was not compared with any other treatment for NSCLC or with placebo (dummy treatment).

What are the risks associated with Tabrecta?

The most common side effects with Tabrecta (which may affect more than 1 in 5 people) are peripheral oedema (swelling especially of the hands, ankles or feet), nausea (feeling sick), tiredness, an increase in creatinine levels in the blood (a sign of kidney problems), vomiting, difficulty breathing, decreased appetite and back pain.The most common serious side effects with Tabrecta are difficulty breathing, interstitial lung disease(a disorder causing scarring in the lungs) and pneumonitis (inflammation in the lungs), cellulitis (inflammation of the deep skin tissue), peripheral oedema and increased levels in the blood of a liver enzyme called alanine aminotransferase (ALT), as well as of amylase and/or lipase (a sign of pancreatic problems).For the full list of side effects and restrictions of Tabrecta, see the package leaflet.

Why is Tabrecta authorised in the EU?

Although the main study did not compare Tabrecta with another cancer treatment, it showed that this medicine is effective in previously treated patients with NSCLC whose cancer was advanced and had the 'METex14 skipping' mutation. The side effects of Tabrecta were considered manageable.The European Medicines Agency therefore decided that Tabrecta'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 Tabrecta?

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


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Tacforius


What is Tacforius and what is it used for?

Tacforius is used for the long-term treatment of adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ). Tacforius can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.Tacforius contains the active substance tacrolimus and is a 'generic medicine'. This means that Tacforius contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Advagraf. For more information on generic medicines, see the question-and-answer document here.

How is Tacforius used?

Tacforius is available as prolonged-release capsules containing tacrolimus. The prolonged-release capsules allow tacrolimus to be released slowly from the capsule over several hours so that it needs to be taken only once a day.Doses of Tacforius are calculated on the basis of the patient's weight and the type of transplant the patient has had. Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily. The doses arethen adjusted according to the patient's response and the medicine's blood levels. Tacforius should be taken once daily with water, on an empty stomach. For further information, see the package leaflet.Tacforius can only be obtained with a prescription. Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe it and make changes to immunosuppressive treatment.

How does Tacforius work?

Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine. Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).

How has Tacforius been studied?

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

What are the benefits and risks of Tacforius?

Because Tacforius 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 Tacforius approved?

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

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

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


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Tachosil


What is TachoSil and what is it used for?

TachoSil is a sponge sealant patch used in adults and children from 1 month of age:• during an operation, to stop bleeding and seal the surfaces of internal organs;• as a support to stitching during surgery on blood vessels when standard techniques are not sufficient.TachoSil is also used in adults during neurological surgery to seal the dura mater (a membrane that surrounds and protects the brain) to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).The TachoSil patch is coated with the active substances human fibrinogen and human thrombin.

How is TachoSil used?

TachoSil should only be used by an experienced surgeon under sterile conditions.TachoSil should only be applied directly onto the treatment site. The sponge should be applied so that it covers 1 to 2 cm beyond the edge of the wound. The size and number of TachoSil sponges to be used depends on the size of the wound. Sponges can be cut to size if needed. TachoSil must not be applied inside a blood vessel.For more information about how TachoSil is used, see the package leaflet or contact your healthcare provider.

How does TachoSil work?

The active substances in TachoSil, fibrinogen and thrombin, are blood proteins involved in the natural clotting process. Thrombin works by converting fibrinogen into smaller units called fibrin, which then stick together to form a local clot.When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot. The clot enables the patch to stick more firmly to the tissue, helping to stop the bleeding and sealing the wound.In neurological surgery, it works by sealing together the cut areas of the outermost layer (dura mater) of the membranes around the brain. This way, it prevents the CSF from leaking.The TachoSil patch is left in the body, where it dissolves and disappears completely.

What benefits of TachoSil have been shown in studies?

Two studies looked at the effects of TachoSil in stopping bleeding. The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in 240 adults having liver surgery. The main measure of effectiveness was the time until the bleeding stopped. TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery. In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively.A third study compared TachoSil with standard stitching in 185 patients having kidney surgery. The main measure of effectiveness was the time until the bleeding stopped. TachoSil was more effective than stitching at stopping bleeding during kidney surgery. The average time until bleeding stopped was5.3 minutes with TachoSil compared with 9.5 minutes with standard stitching.Two additional studies were carried out to test if TachoSil could be used as a tissue sealant. The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery. Effectiveness was measured by looking at whether air leaked from the lungs after surgery. The first study was not sufficient to support the use of TachoSil in sealing tissue since very few patients in the study had any air leakage. However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.A sixth study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels. The study compared TachoSil with standard materials in 120 patients, of whom around three-quarters also had surgery on vessels with stitches and one-quarter had surgery on the heart. The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes. TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart and blood vessels. After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).A seventh study involved 726 patients and compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery. TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.There are limited data available on the use of TachoSil in children. However, data from two studies which involved a limited number of children and additional information from the medical literature show that TachoSil can also be used in children for sealing tissues and blood vessels during surgery.

What are the risks associated with TachoSil?

For the full list of all side effects and restrictions with TachoSil, see the package leaflet.TachoSil may cause an allergic reaction, thrombosis (blood clots), a blockage in the intestine when used during abdominal surgeries, the formation of scar tissue and foreign body granuloma (a type of inflammatory reaction). Patients may also develop antibodies to the proteins in TachoSil, which could reduce its ability to stop bleeding. These side effects are rare and their frequency is not known.TachoSil must not be applied inside a blood vessel as this may lead to thromboembolic complications (blood clots in vessels).

Why is TachoSil authorised in the EU?

TachoSil has been shown to be effective in adults and children from 1 month of age as a supportive treatment during surgery to seal the surfaces of internal organs, promote blood clotting, reduce bleeding and support sutures during surgery on blood vessels when standard techniques are insufficient. TachoSil has also been shown to be effective in adults during neurological surgery to prevent leakage of the CSF. In addition, observed side effects of TachoSil are rare. Therefore, the European Medicines Agency decided that TachoSil'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 TachoSil?

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


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Tadalafil Lilly


What is Tadalafil Lilly and what is it used for?

Tadalafil Lilly is a medicine used to treat men with erectile dysfunction (sometimes called impotence).It can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous, which leads to problems with the flow of urine).Tadalafil Lilly contains the active substance tadalafil and is the same as Cialis, which is already authorised in the European Union (EU). The company that makes Cialis has agreed that its scientific data can be used for Tadalafil Lilly ('informed consent').

How is Tadalafil Lilly used?

Tadalafil Lilly is available as tablets (2.5, 5, 10 and 20 mg) to be taken by mouth. For erectile dysfunction, the usual dose is 10 mg at least 30 minutes before sexual activity. The dose may be increased to 20 mg if the 10 mg dose is not effective. Men who intend to use Tadalafil Lilly frequently (twice a week or more) can take a lower dose (5 or 2.5 mg) once a day, based on the doctor's judgement. The medicine should be taken around the same time every day and the need for the oncea-day dosing should be assessed regularly.In men with benign prostatic hyperplasia, or both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Tadalafil Lilly work?

The active substance of Tadalafil Lilly, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection. By blocking the breakdown of cGMP, Tadalafil Lilly restores erectile function during sexual stimulation and also improves the blood flow to, and relaxes the muscles of, the prostate and bladder. This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.

What benefits of Tadalafil Lilly have been shown in studies?

Tadalafil Lilly has been shown to improve the ability to get and maintain an erection in nine main studies involving over 2,000 men with erectile dysfunction. All the studies compared Tadalafil Lilly with placebo (a dummy treatment) and measured improvements using questionnaires completed before and after treatment.Six of the studies included 1,328 patients who took the medicine before sexual activity. Results for one of the questionnaires, in which men rated their condition on a scale of 0 (indicating severe erectile dysfunction) to 30 (no erectile dysfunction), showed that patients improved from about 15 before treatment, to 23 and 25 after treatment with Tadalafil Lilly 10 and 20 mg, respectively. The other three studies included 853 patients taking Tadalafil Lilly once a day at doses of 2.5 or 5 mg. Results also reported improved erections with Tadalafil Lilly compared with those taking placebo.Tadalafil Lilly has also been shown to improve the symptoms of benign prostatic hyperplasia as measured using the international prostate symptom score (IPSS), which ranges from 0 (no symptoms) to 35 (severe symptoms). In four main studies involving 1,500 patients, some of whom also had erectile dysfunction, patients taking Tadalafil Lilly at a dose of 5 mg had greater reductions in IPSS (4.8 to 6.3 points) after 12 weeks than those taking placebo (2.2 to 4.4 points).

What are the risks associated with Tadalafil Lilly?

The most common side effects with Tadalafil Lilly are headache, indigestion, back pain and muscle pain, which are more common at higher doses. For the full list of all side effects with Tadalafil Lilly, see the package leaflet.Tadalafil Lilly must not be used in men with certain cardiovascular (heart and blood vessel) conditions or when sexual activity is inadvisable. It must also not be taken by patients who have ever had loss of vision in one eye because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION). Tadalafil Lilly must not be taken with nitrates (a type of medicine used for angina) or medicines of the class 'guanylate cyclase stimulators' such as riociguat (a medicine for high blood pressure in the vessels supplying the lungs, known as pulmonary hypertension). For the full list of restrictions, see the package leaflet.

Why is Tadalafil Lilly approved?

As shown in studies, Tadalafil Lilly is effective at improving the ability to get and maintain erections and at relieving the symptoms of benign prostatic hyperplasia. The side effects seen with the medicine are considered manageable. The Agency's Committee for Medicinal Products for Human Use (CHMP)therefore concluded that Tadalafil Lilly's benefits are greater than its risks and recommended that it be approved for use in the EU.

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

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


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Tadalafil Mylan


What is Tadalafil Mylan and what is it used for?

Tadalafil Mylan is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Tadalafil Mylan to be effective in this condition, sexual stimulation is required.Tadalafil Mylan can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.Tadalafil Mylan contains the active substance tadalafil. It is a 'generic medicine'. This means thatTadalafil Mylan is similar to a 'reference medicine' already authorised in the European Union (EU) called Cialis. For more information on generic medicines, see the question-and-answer document here.

How is Tadalafil Mylan used?

For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken 'on demand' at least 30 minutes before sexual activity. The dose may be increased to 20 mg for men who do not respond to the 10 mg dose. The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended. Tadalafil Mylan can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based onthe doctor's judgment. The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated. The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.Patients with severely impaired liver or kidney function should not take more than 10 mg in one dose. Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine.Tadalafil Mylan can only be obtained with a prescription.

How does Tadalafil Mylan work?

The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called'phosphodiesterase type 5 (PDE5) inhibitors'. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection. Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection. By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function. However, sexual stimulation is still needed. By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder. This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.

How has Tadalafil Mylan been studied?

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

What are the benefits and risks of Tadalafil Mylan?

Because Tadalafil 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 Tadalafil Mylan approved?

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

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

A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of productcharacteristics and the package leaflet for Tadalafil Mylan, 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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Tafinlar


What is Tafinlar and what is it used for?

Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called 'BRAF V600'. It is used for the treatment of:• melanoma (a skin cancer) that has spread or cannot be removed surgically. Tafinlar is used on its own or in combination with another cancer medicine, trametinib;• advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;• advanced non-small cell lung cancer. It is used in combination with trametinib.Tafinlar contains the active substance dabrafenib.

How is Tafinlar used?

Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of cancer medicines. The medicine can only be obtained with a prescription.Tafinlar is available as capsules (50 and 75 mg). The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal).Tafinlar can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back. Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur.For more information about using Tafinlar, see the package leaflet or contact your doctor or pharmacist.

How does Tafinlar work?

The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division. In melanoma and non-small cell lung cancer with the BRAF V600 mutation, the abnormalform of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells. By blocking the action of the abnormal BRAF, Tafinlar helps to slow down the growth and spread of the cancer.

What benefits of Tafinlar have been shown in studies?

Tafinlar has been studied in patients whose cancer had the BRAF V600 mutation.MelanomaTafinlar was more effective than the cancer medicine dacarbazine at controlling melanoma that had spread to other parts of the body or could not be removed surgically. This was based on one main study involving 250 patients, which measured how long patients lived until their disease got worse. Patients taking Tafinlar lived on average 6.9 months before the disease got worse, compared with 2.7 months in patients given dacarbazine.Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Tafinlar with trametinib. In one study 423 patients were given either the combination or Tafinlar alone. Patients given the combination lived for 11 months without their disease worsening, compared with 8.8 months for those given Tafinlar alone. In a second study involving 704 patients, Tafinlar with trametinib was compared with another medicine for melanoma, vemurafenib. Patients given the combination lived 25.6 months on average, versus 18 months with vemurafenib.In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Tafinlar and trametinib given for 1 year was compared with placebo (a dummy treatment). Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.Non-small cell lung cancerIn one main study, 171 patients with non-small cell lung cancer received either Tafinlar combined with trametinib or Tafinlar alone. The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and patients' clinical data. The use of Tafinlar and trametinib led to a response in over 60% of the patients, compared with 23% of patients using Tafinlar alone.

What are the risks associated with Tafinlar?

The most common side effects with Tafinlar (which may affect more than 1 in 10 people) are papilloma (warts), headache, nausea, vomiting, hyperkeratosis (thickening and toughening of the skin), hair loss, rash, joint pain, fever and tiredness.When Tafinlar is taken in combination with trametinib, the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.For the full list of side effects and restrictions with Tafinlar, see the package leaflet.

Why is Tafinlar authorised in the EU?

The European Medicines Agency decided that Tafinlar's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU. The Agency consideredthat Tafinlar when used alone or in combination with trametinib had shown clinically relevant benefit in patients with advanced non-small cell lung cancer or with melanoma that had spread or could not be removed surgically. The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically. Tafinlar's side effects were considered acceptable and manageable with appropriate measures.

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

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


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Tagrisso


What is Tagrisso and what is it used for?

Tagrisso is a medicine for treating a lung cancer called non-small cell lung cancer (NSCLC).It is used on its own in patients whose cancer cells have certain mutations (changes) in a gene for a protein called EGFR.• In patients whose cancer cells have genetic changes known as Ex19del or L858R and whose cancer has not spread to other organs and has been completely removed by surgery, the medicine is given to help prevent the cancer from coming back (adjuvant therapy).• In patients whose cancer cells have mutations known as 'activating mutations' and whose cancer is advanced or has spread, Tagrisso is given as the first treatment.• In patients whose cancer cells have T790M mutations and whose cancer is advanced or has spread, the medicine may be given after other treatments.Tagrisso contains the active substance osimertinib.

How is Tagrisso used?

Tagrisso can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the use of cancer medicines. Before starting treatment, the doctor should use a genetic test to confirm that the patient has an EGFR mutation.Tagrisso is available as 40 and 80 mg tablets. The patient should take 80 mg once a day for as long as the disease improves or remains stable, or does not come back after surgery, and the side effects are tolerable. If certain side effects develop, the doctor may decide to reduce the dose or stop treatment.For more information about using Tagrisso, see the package leaflet or contact your doctor or pharmacist.

How does Tagrisso work?

The active substance in Tagrisso, osimertinib, is a type of cancer medicine called a tyrosine kinase inhibitor. It blocks the activity of EGFR, which normally controls growth and division of cells. In lungcancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells. By blocking EGFR, osimertinib helps to reduce the growth and spread of the cancer.

What benefits of Tagrisso have been shown in studies?

Four studies have found Tagrisso to be effective at shrinking tumours in patients with NSCLC and at slowing down the worsening of the cancer. Another study found it was effective at helping to prevent the cancer from coming back in patients who had surgery to completely remove the cancer.In two studies involving 411 previously treated patients who had T790M mutations, the overall response rates (the proportion of patients whose tumours shrank) with Tagrisso was 66% and the response lasted an average of 12.5 months. In these studies, Tagrisso was not compared with any other treatment.A third study in 419 previously treated patients with T790M mutations looked mainly at how effective Tagrisso was at preventing the cancer from worsening, comparing it with a platinum-based chemotherapy (the standard treatment for NSCLC). In patients taking Tagrisso, the cancer did not get worse for around 10.1 months compared with 4.4 months in patients on chemotherapy.In a fourth study of 556 patients with activating mutations, patients taking Tagrisso as a first treatment lived for 18.9 months without their disease getting worse compared with 10.2 months in patients receiving treatment with other medicines (either erlotinib or gefitinib).Finally, in a study involving 682 patients with Ex19del or L858R mutations who had surgery to completely remove the cancer, 89% (302 out of 339) of patients taking Tagrisso were still alive and disease-free after at least 1 year of treatment compared with 54% (184 out of 343) of patients taking a placebo.

What are the risks associated with Tagrisso?

The most common side effects with Tagrisso (which may affect more than 1 in 10 people) are diarrhoea, rash, paronychia (nail bed infection), dry skin, stomatitis (inflammation of the lining of the mouth), decreased appetite, itching, and a decrease in the levels of white blood cells and platelets.Tagrisso must not be used together with St. John's wort (a herbal preparation used to treat depression).For the full list of restrictions and side effects with Tagrisso, see the package leaflet.

Why is Tagrisso authorised in the EU?

Patients whose cancer cells have EGFR mutations have a poor prognosis and limited treatment options; therefore, there is a high unmet medical need. Tagrisso has been shown in studies to be effective at shrinking tumours in patients with these mutations and at slowing down the worsening of the cancer. The medicine is also effective at preventing the cancer from coming back in patients with EGFR mutations who have had surgery to completely remove the cancer. Regarding safety, the adverse effects with Tagrisso are similar to other medicines of the same class and are considered acceptable.The European Medicines Agency therefore concluded that Tagrisso'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 Tagrisso?

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


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Takhzyro


What is Takhzyro and what is it used for?

Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 12 years and over.Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs. Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.Takhzyro contains the active substance lanadelumab.
Hereditary angioedema is rare, and Takhzyro was designated an 'orphan medicine' (a medicine used in rare diseases) on 9 October 2015. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551

How is Takhzyro used?

Takhzyro is given as an injection under the skin, preferably in the abdomen (belly), thighs or upper arms. The recommended starting dose of Takhzyro is 300 mg every 2 weeks. If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.

How does Takhzyro work?

Patients with hereditary angioedema have high levels of a substance called 'bradykinin', which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin. By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.

What benefits of Takhzyro have been shown in studies?

Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks. This compared with 2 attacks per month for patients on placebo (a dummy treatment).

What are the risks associated with Takhzyro?

The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.For the full list of side effects and restrictions with Takhzyro, see the package leaflet.

Why is Takhzyro authorised in the EU?

Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments. Overall, the safety profile was considered acceptable.The European Medicines Agency therefore decided that Takhzyro'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 Takhzyro?

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


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Talmanco


What is Talmanco and what is it used for?

Talmanco is a medicine used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the lungs. Talmanco is used in patients with class-II (slight limitation of physical activity) or class-III (marked limitation of physical activity) PAH.Talmanco contains the active substance tadalafil.Talmanco is a 'generic medicine'. This means that Talmanco contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Adcirca. For more information on generic medicines, see the question-and-answer document here.

How is Talmanco used?

Talmanco 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.1 Previously known as Tadalafil Generics.Talmanco is available as 20 mg tablets. The recommended dose is two tablets (40 mg) once a day. Patients with mild or moderate kidney or liver problems should be started on a lower dose. Talmanco is not recommended for patients with severe kidney or liver problems.

How does Talmanco work?

PAH is a debilitating disease where there is severe 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 Talmanco, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs. When the enzyme is blocked, a substance called 'cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes widening of the blood vessels. In patients with PAH, this lowers the blood pressure in the lungs and improves symptoms.

How has Talmanco been studied?

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

What are the benefits and risks of Talmanco?

Because Talmanco 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 Talmanco approved?

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

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

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


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Taltz


What is Taltz and what is it used for?

Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin. It is used in adults who require systemic treatment (treatment with medicines affecting the whole body).Taltz contains the active substance ixekizumab.

How is Taltz used?

Taltz can only be obtained with a prescription and it should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis.Taltz is available as an injection in pre-filled syringes and in pen injectors. It is given as an injection under the skin. The first dose of 160 mg (two injections) is followed by an injection of 80 mg every two weeks for the first 12 weeks and every 4 weeks thereafter. The doctor may decide to stop treatment if the condition does not improve after 16 to 20 weeks. After training, patients may inject Taltz if their doctor considers it appropriate. For further information, see the summary of product characteristics (also part of the EPAR).

How does Taltz work?

The active substance in Taltz, ixekizumab, is a monoclonal antibody, a protein designed to attach to interleukin 17A, a messenger molecule in the body's immune system (the body's natural defences). Interleukin 17A is involved in immune system effects, including inflammation, that cause psoriasis. By attaching to interleukin 17A, ixekizumab blocks its action and reduces the activity of the immune system and thereby reduces the symptoms of psoriasis.

What benefits of Taltz have been shown in studies?

Studies show that Taltz is effective in treating plaque psoriasis in patients who required systemic treatment. Plaque psoriasis improved to a greater extent in patients treated with Taltz than with placebo (a dummy treatment) or with etanercept, another medicine used to treat psoriasis.In 3 main studies involving over 3,800 patients with psoriasis, 89% of those treated every two weeks with Taltz attained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks. This compares with 4% of those given placebo and with 48% of patients given etanercept in 2 of the main studies. Also, 82% of patients given Taltz had clear or nearly clear skin after 12 weeks, compared with 4% of patients given placebo and 39% of patients given etanerceptIn 2 studies, treatment was continued in patients whose psoriasis improved with Taltz given every 2 weeks for 12 weeks. After further treatment with Taltz every 4 weeks for 48 weeks, 78% of patients had clear or nearly clear skin.

What are the risks associated with Taltz?

The most common side effects with Taltz (which may affect more than 1 in 10 people) are pain and redness at the injection site, and nose, throat or chest infections. Taltz must not be given to patients who have potentially serious infections such as tuberculosis. For the full list of all side effects and restrictions with Taltz, see the package leaflet.

Why is Taltz approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Taltz's benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be effective in moderate to severe plaque psoriasis and its side effects are in line with other similar psoriasis medicines.

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

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


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Talvey


What is Talvey and what is it used for?

Talvey is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has come back (relapsed) and has not responded to treatment (refractory).It is used in patients who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose disease has worsened since the last treatment.Multiple myeloma is rare, and Talvey was designated an 'orphan medicine' (a medicine used in rare diseases) on 20 August 2021. Further information on the orphan designation can be found on the EMA website.Talvey contains the active substance talquetamab.

How is Talvey used?

The medicine can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of multiple myeloma. It should be given in a setting with appropriate medical support to manage possible severe side effects such as cytokine release syndrome (a potentially life-threatening condition that causes fever, vomiting, shortness of breath, headache and low blood pressure) and neurological toxicity (complications relating to the brain or nerves; see risks section below for further information).Talvey is given as an injection under the skin, either once a week or every 2 weeks. Treatment should continue for as long as the patient benefits from it or until side effects become unmanageable. Several medicines are given before Talvey to reduce the risk of cytokine release syndrome. Doctors should monitor patients for serious side effects for 2 days after each of the first 3 or 4 doses. The doctor may delay doses if certain side effects occur or stop treatment altogether for certain severe side effects.For more information about using Talvey, see the package leaflet or contact your doctor or pharmacist.

How does Talvey work?

The active substance in Talvey, talquetamab, is an antibody (a type of protein) that is designed to recognise and attach to two targets simultaneously: one called GPRC5D on myeloma cells and one called CD3 on the surface of T cells (a type of cell in the immune system). By attaching to these target proteins, Talvey brings the cancer cells and T cells together. This activates the T cells, which then kill the multiple myeloma cells.

What benefits of Talvey have been shown in studies?

Talvey was investigated in one main study involving 288 patients with relapsed or refractory multiple myeloma that had returned and who had been given 3 or more previous treatments. Patients were given either Talvey 4 mg/kg bodyweight once a week or Talvey 8 mg/kg once every two weeks. Several markers were used to measure response to treatment, including urine and blood levels of an antibody called M protein. Talvey was not compared to another medicine in this study.The study showed that 74.1% (106 out of 143) of patients given Talvey 4 mg/kg once a week had at least a partial response to treatment (meaning their blood level of M protein had decreased by at least 50%); in 51.5% of responders, the response lasted for at least 9 months. Among patients given Talvey 8 mg/kg once every two weeks, 71.7% (104 out of 145) had at least a partial response to treatment, which lasted for at least 9 months in 76% of responders.

What are the risks associated with Talvey?

For the full list of side effects and restrictions with Talvey, see the package leaflet.The most common side effects with Talvey (which may affect more than 6 in 10 people) include cytokine release syndrome (CRS), dysgeusia (taste disturbance) and hypogammaglobulinaemia (low levels of antibodies in the blood). More than 2 in 10 people may be affected by the following side effects: nail disorder, pain in muscles and bones, anaemia (low levels of red blood cells), skin disorder, tiredness, decreased weight, rash, dry mouth, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), fever, xerosis (severely dry skin), thrombocytopenia (low levels of blood platelets), nose and throat infection, lymphopenia (low levels of lymphocytes, a type of white blood cell), dysphagia (difficulty swallowing), diarrhoea, pruritus (itching), cough, pain, decreased appetite and headache.Serious side effects include CRS, fever, immune effector cell-associated neurotoxicity syndrome (ICANS, a neurological disorder with symptoms including problems with speech and writing, confusion and depressed level of consciousness), sepsis (blood poisoning), COVID-19, bacterial infection, pneumonia (lung infection), viral infection, neutropenia and pain.

Why is Talvey authorised in the EU?

Patients with multiple myeloma whose cancer has returned and not responded to at least 3 previous treatments have limited treatment options. in these patients. Talvey was shown to produce high response rates in these patients and could represent an additional treatment option.Although serious side effects, particularly cytokine release syndrome and ICANS, can occur, they were considered manageable with appropriate measures. The European Medicines Agency therefore decided that Talvey's benefits are greater than its risks and it can be authorised for use in the EU.Talvey has been given 'conditional authorisation'. This means that the European Medicines Agency decided that the benefits of Talvey are greater than its risks, but the company will have to provide additional evidence after authorisation.Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available until data become comprehensive, and this overview will be updated as necessary.Since Talvey was given conditional authorisation, at the time of authorisation the company marketing Talvey was required to provide data from an additional study in order to confirm the effectiveness and safety of the medicine. The company was also required to provide further data to characterise the long-term safety of Talvey.

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

The company that markets Talvey will provide educational materials to healthcare professionals expected to prescribe or give the medicine, containing important information on the risk of neurological toxicity including ICANS; an alert card will be provided to patients receiving the medicine, containing important information on the risk of CRS and neurological toxicity, including ICANS, and recommendations to help minimise these risks.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talvey have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Talvey are continuously monitored. Suspected side effects reported with Talvey are carefully evaluated and any necessary action taken to protect patients.


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Talzenna


What is Talzenna and what is it used for?

Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.Talzenna contains the active substance talazoparib.

How is Talzenna used?

Talzenna can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.Talzenna is available as capsules (1 mg and 0.25 mg) and the recommended dose is 1 mg once a day. Treatment should continue for as long as the patient continues to benefit from it and side effects are tolerable. The dose may be reduced or treatment interrupted if certain side effects develop.For more information about using Talzenna, see the package leaflet or contact your doctor or pharmacist.

How does Talzenna work?

The active substance in Talzenna, talazoparib, blocks the action of enzymes called human poly-ADP ribose polymerase (PARP), which are proteins that help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division. Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and as a result the cancer cells die.

What benefits of Talzenna have been shown in studies?

Talzenna was shown to be effective at increasing the time patients live without their disease getting worse in one main study involving 431 patients with HER2-negative breast cancer with BRCA mutations whose cancer had spread. Patients treated with Talzenna lived on average for 8.6 months without their disease getting worse compared with 5.6 months for patients treated with the doctor's choice of another cancer medicine.

What are the risks associated with Talzenna?

The most common side effects with Talzenna (which may affect more than 1 in 4 people) are tiredness, anaemia (low red blood cell counts which can cause tiredness and pale skin), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), thrombocytopenia (low blood levels of platelets), and headache. The most common severe side effects (which may affect more than 1 in 10 people) which led to changes in the dose of Talzenna are anaemia, neutropenia and thrombocytopenia.Women must not breastfeed during treatment with Talzenna and for a month after stopping treatment. For the full list of side effects and restrictions with Talzenna, see the package leaflet.

Why is Talzenna authorised in the EU?

Generally the outcome is poor for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread. Talzenna can increase the time these patients live without their disease getting worse. The side effects with Talzenna were generally well-tolerated and when needed, manageable with dose modifications, and/or standard supportive medical therapy.The European Medicines Agency therefore decided that Talzenna'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 Talzenna?

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


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Tamiflu


What is Tamiflu and what it is used for?

Tamiflu is an antiviral medicine used to treat or prevent influenza (flu).• to treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community;• to prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community. This is generally done on a caseby-case basis. Tamiflu can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu). During a flu pandemic, Tamiflu can also be used to prevent flu in babies below 1 year of age.Tamiflu cannot replace flu vaccination, and its use should be based on official recommendations.The medicine contains the active substance oseltamivir.

How is Tamiflu used?

Tamiflu is available as capsules (30 mg, 45 mg, and 75 mg) and as a powder that is made up into a liquid to be drunk (6 mg/ml and 12 mg/ml).In the treatment of flu, Tamiflu must be started within two days of the onset of symptoms. The usual dose for adults and children weighing more than 40 kg is 75 mg given twice a day for 5 days. For adults with a weakened immune system (the body's natural defences), it is given for 10 days.In the prevention of flu, Tamiflu must be started within two days of contact with someone who has flu.The usual dose for adults and children weighing more than 40 kg is 75 mg given once a day for at least 10 days after contact with an infected person. When Tamiflu is used during a flu epidemic, it is given for up to 6 weeks.The medicine can only be obtained with a prescription. For more information about using Tamiflu, see the package leaflet or contact your doctor or pharmacist.

How does Tamiflu work?

The active substance in Tamiflu, oseltamivir, acts on the flu virus, blocking some of the enzymes on its surface known as neuramidases. When the neuramidases are blocked, the virus cannot spread. Oseltamivir works on the neuramidases of both influenza A (the most common type) and influenza B viruses.

What benefits of Tamiflu have been shown in studies?

Treatment of fluTamiflu reduced the duration of the illness compared with placebo (a dummy treatment) in several studies (involving 2,413 patients aged 13 years or over, 741 elderly patients aged 65 years or over and 1,033 children aged between 1 and 12 years). Effectiveness was measured by recording symptoms (feeling feverish, muscle pain, headache, sore throat, cough, overall discomfort and runny nose). In adults, the duration of the illness was reduced from an average of 5.2 days for patients taking placebo, to 4.2 days for patients taking Tamiflu. The average reduction in the duration of the illness in children aged 1 to 6 years was 1.5 days.Prevention of fluTamiflu reduced the incidence of flu in people who had come into contact with the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 people aged between 16 and 65 years, and 548 elderly people in nursing homes). The studies measured the number of cases of flu proven by laboratory tests. A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with the person.In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo. In families with one patient who had flu, 7% of the family members in the household developed flu when receiving Tamiflu, compared with 20% of those receiving no preventative treatment.

What are the risks associated with Tamiflu?

The most common side effects with Tamiflu (seen in more than 1 patient in 10) in adults and adolescents are headache and nausea (feeling sick). In children the most common side effects (seen in more than 1 patient in 10) are vomiting, cough and nasal congestion (a blocked nose). For the full list of side effects and restrictions with Tamiflu, see the package leaflet.

Why is Tamiflu authorised in the EU?

When used for treatment of flu, Tamiflu reduces the duration of illness in adults and children. It can also reduce the incidence of flu in patients who had come into contact with the disease or during a pandemic. Side effects are generally mild or moderate in severity.The European Medicines Agency decided that Tamiflu's benefits are greater than its risks and recommended that it can be authorised for use in the EU.

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

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


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Tandemact


What is Tandemact?

Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride. It is available as tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).

What is Tandemact used for?

Tandemact is used to treat adult patients who have type 2 diabetes. It is used in patients for whom metformin (a type of diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances pioglitazone and glimepiride.The medicine can only be obtained with a prescription.

How is Tandemact used?

The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day. The tablet should be swallowed whole with a little water. Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact. Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.Treatment with Tandemact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

How does Tandemact work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. Tandemact contains two active substances, each of which has a different mode of action. Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin. As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.

How has Tandemact been studied?

Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature. Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. The company used three studies to support the use of Tandemact in the same indication.The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea. The studies lasted between four months and two years and measured the level of asubstance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.These studies used pioglitazone and sulphonylureas given as separate tablets. The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.

What benefit has Tandemact shown during the studies?

In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose. The patients' HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%. At least 64% of the patients treated were classified as 'responders', since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.

What is the risk associated with Tandemact?

The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema (swelling). For the full list of all side effects reported with Tandemact, see the package leaflet.Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys. It must not be used in patients with type 1 diabetes, patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding. It must also not be used in patients who have or have had bladder cancer or those withblood in the urine that has not yet been investigated. For the full list of restrictions, see the package leaflet.

Why has Tandemact been approved?

The CHMP concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed. The Committee decided that Tandemact'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 Tandemact?

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


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Tarceva


What is Tarceva and what is it used for?

Tarceva is a cancer medicine used in non-small-cell lung cancer (NSCLC) that is advanced (the cancer has started to spread) or metastatic (it has already spread to other parts of the body). It is used for:• previously untreated patients whose cancer cells have certain changes ('activating mutations') in the gene for a protein called epidermal growth factor receptor (EGFR);• patients with EGFR activating mutations whose disease is stable after initial chemotherapy. Stable means that the cancer has neither improved nor worsened with chemotherapy (medicines to treat cancer);• patients with EGFR activating mutations in whom previous chemotherapy has not worked;• patients without EGFR activating mutations in whom previous chemotherapy has not worked and other treatments are unsuitable.Tarceva is also used in patients with metastatic pancreatic cancer, in combination with gemcitabine (another cancer medicine).The medicine contains the active substance erlotinib.

How is Tarceva used?

Tarceva can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines. Patients with NSCLC should be tested for EGFR activating mutation before starting Tarceva, unless previous chemotherapy has not worked and other treatments are not suitable.The medicine is available as tablets (25, 100 and 150 mg). For NSCLC, the usual dose is 150 mg daily. For pancreatic cancer, it is 100 mg daily. Tarceva is taken at least one hour before or two hours after food. If needed (for example because of side effects), the dose may be reduced in 50-mg steps. As Tarceva seems more effective in patients with pancreatic cancer who develop a rash, treatment should be re-assessed after 4 to 8 weeks if no rash has developed. Patients taking Tarceva should stop smoking, as smoking can decrease the amount of the medicine in the blood.For more information about using Tarceva, see the package leaflet or contact your doctor or pharmacist.

How does Tarceva work?

The active substance in Tarceva, erlotinib, belongs to the group 'EGFR inhibitors'. Erlotinib blocks EGFRs, which can be found on some tumour cells. As a result of this block, the tumour cells can no longer receive the messages needed for growing and for spreading (metastasis). As a result, Tarceva helps to stop the cancer from growing and spreading through the body.

What benefits of Tarceva have been shown in studies?

NSCLCIn NSCLC, Tarceva has been mainly studied in four studies.• The first study compared Tarceva with chemotherapy in 173 patients with advanced NSCLC with activating EGFR mutations who had not received previous chemotherapy. Patients taking Tarceva lived for an average of 10.4 months without their disease getting worse compared with 5.1 months for those receiving chemotherapy medicines.• The second study compared Tarceva with placebo (a dummy treatment) in 889 patients with advanced or metastatic NSCLC whose disease had not got worse after 4 cycles of treatment with platinum-containing chemotherapy. Overall, Tarceva marginally increased how long patients lived without their disease getting worse and how long they survived. The greatest benefit was in a subgroup of 49 patients with EGFR activating mutations: those taking Tarceva (22 patients) lived for an average of 44.6 weeks without their disease getting worse, compared with 13 weeks for those taking placebo (27 patients).• A third study compared Tarceva with placebo in 643 patients with advanced NSCLC whose cancer cells did not have EGFR activating mutations and whose disease was stable after 4 cycles of treatment with platinum-containing chemotherapy. The study compared how long patients survived when Tarceva was used early in the study with how long they survived when Tarceva was used later in the study. The study found no advantage to early use of the medicine, as patients treated with Tarceva early in the study did not live longer than those treated with Tarceva later in the study (after the disease had progressed).• The fourth study compared Tarceva with placebo in 731 patients in whom at least one previous chemotherapy treatment had not worked. Patients taking Tarceva survived for an average of 6.7 months, compared with 4.7 months for the patients taking placebo. Among the patients who tookTarceva, the average survival was 8.6 months in those whose tumours were 'EGFR IHC-positive'(had EGFRs on the cell surface), and 5.0 months in those whose tumours were EGFR IHC-negative.Pancreatic cancerTarceva in combination with gemcitabine was studied in 569 patients with pancreatic cancer that was advanced, unresectable (that cannot be removed by surgery) or metastatic. Patients with metastatic cancer taking Tarceva as initial therapy lived without their disease getting worse for an average of 5.9 months, compared with 5.1 months in those taking placebo. However, there was no advantage for patients whose cancer had not spread beyond the pancreas.

What are the risks associated with Tarceva?

In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (affecting 75% of patients), diarrhoea (54%), loss of appetite and tiredness (52% each). In the study of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects were tiredness (affecting 73% of patients), rash (69%) and diarrhoea (48%). For the full list of side effects and restrictions with Tarceva, see the package leaflet.

Why is Tarceva authorised in the EU?

Tarceva can prolong the time the patients live without their disease getting worse and prolong life in some patients. The side effects reported with Tarceva are considered manageable.The European Medicines Agency therefore decided that Tarceva'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 Tarceva?

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


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Targretin


What is Targretin and what is it used for?

Targretin is a cancer medicine used for the treatment of the visible signs on the skin of cutaneous Tcell lymphoma (CTCL). CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin. Targretin is used in patients who have an advanced disease and have had at least one other treatment.

How is Targretin used?

Targretin can only be obtained with a prescription and treatment should only be initiated and maintained by a doctor who has experience in the treatment of patients with CTCL.Targretin is available as capsules (75 mg). The dose of Targretin is based on the patient's body surface area in square metres (m2). The recommended starting dose is 300 mg/m2/day, taken as a single dose once a day with a meal. The dose is adjusted depending on the patient's response to treatment or side effects. Treatment should continue as long as the patient benefits from it.For more information about using Targretin, see the package leaflet or contact your doctor or pharmacist.

How does Targretin work?

The active substance in Targretin, bexarotene, belongs to the group of retinoids, substances that are derived from vitamin A. The exact way bexarotene works in CTCL is not known.

What benefit of Targretin have been shown in studies?

The effectiveness of Targretin has been examined in two studies involving a total of 193 patients with CTCL who received at least two previous treatments. Targretin was not compared with another medicine. Ninety-three of these patients had advanced disease that had not responded to other treatment. Sixty-one patients were treated at the starting dose of 300 mg/m2/day. The main measure of effectiveness was the response to treatment after 16 weeks. This was measured by the doctor'sgrading of improvement, as well as by a score of 5 clinical signs (area of skin affected, redness, raised areas, scale-like skin and colour).Across the two studies, among the patients who received 300 mg/m2, about half of them responded to treatment, according the doctor's grading. The response rates according to the 5 skin scores were 36% and 27%, respectively.

What are the risks associated with Targretin?

The most common side effects with Targretin (which may affect more than 1 patient in 10) are leucopenia (reduced white cell count), hypothyroidism (underactive thyroid gland), hyperlipaemia (high levels of fats in the blood), hypercholesterolaemia (high blood cholesterol), exfoliative dermatitis (skin peeling), pruritus (itching), rash, pain, headache and weakness. For the full list of side effects reported with Targretin, see the package leaflet.Targretin must not be used in women who are pregnant or breast-feeding, or women who could become pregnant and who are not using effective contraception; patients who have had pancreatitis (inflammation of the pancreas); patients with uncontrolled hypercholesterolaemia (high blood cholesterol), hypertriglyceridaemia (high blood triglycerides [fat]) or thyroid disease; patients with hypervitaminosis A (high levels of vitamin A); patients with liver disease; patients with an ongoing body infection. For the full list of restrictions, see the package leaflet.

Why is Targretin authorised in the EU?

The European Medicines Agency decided that Targretin's benefits are greater than its risks for the treatment of the skin manifestations of advanced-stage CTCL patients refractory to at least one treatment. The Agency recommended that Targretin be given marketing authorisation.

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

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


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Tasigna


What is Tasigna and what is it used for?

Tasigna is a medicine for treating chronic myelogenous leukaemia (CML) - a blood cancer - in patients who have been newly diagnosed or who cannot take other cancer medicines (including imatinib) because they cause side effects or do not work for them.Tasigna is only for patients with a special chromosome in their cancer cells called the Philadelphia chromosome. Tasigna is used during the chronic phase of the cancer in adults and children, when the condition is developing slowly and the patient has few or no symptoms. It can also be used in adults during the accelerated phase (when the cancer cells are dividing rapidly and the patient may have more symptoms).CML is rare, and Tasigna 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/Find medicine/Human medicines/Rare disease designation.Tasigna contains the active substance nilotinib.

How is Tasigna used?

The medicine is available as capsules to be taken twice a day on an empty stomach. For patients who are unable to swallow capsules the content of the capsules can be mixed in a teaspoon of apple puree and swallowed.The dose of Tasigna depends on the age of the patient and whether they have previously had treatment for CML, as well as the phase of the disease. Treatment can continue for as long as the patient benefits from it. Adults whose CML is well controlled may stop treatment but should have regular tests to check that the disease has not started to come back. For more information about using Tasigna, see the package leaflet or contact your doctor or pharmacist.Tasigna can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of CML.

How does Tasigna work?

The active substance in Tasigna, nilotinib, belongs to a group of medicines called 'protein kinase inhibitors'. Nilotinib acts by blocking the protein kinase called Bcr-Abl kinase which is produced by leukaemia cells that have the Philadelphia chromosome, and causes them to multiply uncontrollably.By blocking Bcr-Abl kinase, Tasigna helps to control the spread of leukaemia cells.

What benefits of Tasigna have been shown in studies?

A number of studies have shown that Tasigna has important effects which can help keep CML under control. Below is a brief description of the studies and what effects they measured:• A study in 320 adults with chronic phase CML showed that treatment with Tasigna can lead to what is known as a major cytogenetic response (when the proportion of white blood cells in the bone marrow containing the Philadelphia chromosome falls to below 35%). In this study around 49% of patients, most of whom had stopped responding to imatinib, achieved this response after around 11 months on Tasigna treatment.• Another study in 119 adults with accelerated phase CML looked at the haematological response(when the number of white cells in the blood returns to normal). This response was achieved in 42% of patients, most of whom had also stopped responding to imatinib, after around seven months of Tasigna treatment.• A third study in 846 newly diagnosed adults with chronic phase CML compared Tasigna with imatinib. It focused on another measure called a major molecular response (when the proportion of the patient's white blood cells that can produce the abnormal Bcr-Abl kinase falls to below 0.1%). Depending on the dose, between 43% and 44% of patients taking Tasigna achieved this response after 12 months compared with 22% of patients taking imatinib.• Two further studies in adults with chronic phase CML who were treated with Tasigna for at least 3 years and whose disease was well controlled for at least a year showed that the medicine's benefits can be maintained after stopping treatment. In one of the studies in 190 patients initially treated with Tasigna, 52% maintained a response after 48 weeks of stopping Tasigna. In the second study in 126 patients who had been switched from imatinib to Tasigna, 58% maintained their response 48 weeks after stopping Tasigna.• Finally, a study showed that Tasigna was also effective in children with CML in the chronic phase.In this study of 58 children, a major molecular response was achieved with Tasigna at 6 months in 39% of children whose cancer did not respond to other medicines such as imatinib, and 64% of those with newly diagnosed cancer by 12 months.

What are the risks associated with Tasigna?

The most common side effects with Tasigna (which may affect more than 1 in 10 people) are thrombocytopenia (low blood platelet counts), neutropenia (low white blood cell counts), headache, nausea (feeling sick), rash, pruritus (itching), myalgia (muscle pain), upper abdominal (belly) pain, tiredness, hair loss and high blood levels of liver and pancreatic enzymes and bilirubin For the full list of side effects and restrictions with Tasigna, see the package leaflet.

Why is Tasigna approved?

Tasigna has been shown to improve the condition of patients with CML by reduction of the number of cancer cells with the Philadelphia chromosome and return of white blood cell levels to normal. The sideeffects of the medicine are considered to be manageable. The European Medicines Agency therefore decided that Tasigna'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 Tasigna?

The company that markets Tasigna will provide further data on the benefits in children from an ongoing study.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tasigna have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tasigna are continuously monitored. Side effects reported with Tasigna are carefully evaluated and any necessary action taken to protect patients.


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Tasmar


What is Tasmar?

Tasmar is a medicine that contains the active substance tolcapone. It is available as tablets (100 mg and 200 mg).

What is Tasmar used for?

Tasmar is used to treat patients with Parkinson's disease. Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Tasmar is used together with other standard treatments for Parkinson's disease (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patients have 'fluctuations' towards the end of the period between two doses of their standard combination. Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being 'on' and able to move, and being 'off' and immobile. Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.The medicine can only be obtained with a prescription.

How is Tasmar used?

Tasmar treatment should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.Tasmar is always given with levodopa and benserazide or with levodopa and carbidopa. The recommended dose is 100 mg three times a day. The first dose of the day of Tasmar should be takentogether with the first daily dose of the levodopa preparation, and subsequent doses of Tasmar should be given approximately 6 and 12 hours later. The tablets should be swallowed whole.When patients add Tasmar to their existing anti Parkinson's disease medication, they need to be made aware that they may experience some of the side effects of levodopa, although these can often be reduced by lowering the dose of levodopa. The dose of Tasmar may be increased to 200 mg three times a day but only when the benefit expected outweighs the risk of liver injury. If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.Doctors should check the patient's liver before starting treatment with Tasmar and then regularly during treatment. Treatment should be stopped in patients who develop liver problems.

How does Tasmar work?

In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination. It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth. Tolcapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catecholO-methyl transferase (COMT). As a result, levodopa remains active for longer. This helps to improve the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.

How has Tasmar been studied?

Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study. All of the studies compared Tasmar with placebo (a dummy treatment) when they were added to the patient's existing medication (levodopa and either carbidopa or benserazide). The main measure of effectiveness was how long the patients spent in the 'off' or in the 'on' state.Tasmar has also been studied in a 'switch' study in 150 patients. These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT). The study compared continuing to take entacapone with switching to Tasmar. The main measure of effectiveness was the number of patients with an increase in 'on' time of one hour or more, during the three weeks following the switch.

What benefit has Tasmar shown during the studies?

The initial studies showed that Tasmar was more effective than placebo. There was a reduction of about 20 to 30% in 'off' time in patients taking Tasmar.In the switch study, more patients responded to Tasmar (53%; 40 out of 75) than to entacapone (43%; 32 out of 75).

What is the risk associated with Tasmar?

The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), loss of appetite, diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing). Tasmar can cause liver injury, which can be fatal in rare cases. Doctors should monitor patients very carefully during treatment. For the full list of all side effects reported with Tasmar, see the package leaflet.Tasmar must not be used in patients with:• signs of liver disease or increased liver enzymes;• phaeochromocytoma (a tumour of the adrenal gland);• a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke);• severe dyskinesia.Tasmar must also not be used in patients who are being treated with medicines known as nonselective monoamine oxidase (MAO) inhibitors.For the full list of restrictions see the package leaflet.

Why has Tasmar been approved?

The CHMP decided that Tasmar's benefits are greater than its risks in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors. The Committee recommended that Tasmar be given marketing authorisation.

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

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


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Tavlesse


What is Tavlesse and what is it used for?

Tavlesse is a medicine for treating adults with chronic immune thrombocytopenia. It is for use when other treatments have not worked.Chronic immune thrombocytopenia, previously called idiopathic thrombocytopenic purpura (ITP), is a long-term condition in which the immune system (the body's defences) destroys healthy platelets in the blood. Platelets are needed to form clots and stop bleeding. Patients with the disease have low platelet counts and may bruise or bleed easily.Tavlesse contains the active substance fostamatinib.

How is Tavlesse used?

Tavlesse can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of blood diseases. It is available as tablets.The recommended starting dose for Tavlesse is 100 mg twice daily and the doctor then adjusts the dose according to the patient's platelet count and the medicine's side effects. The maximum dose is 150 mg twice daily. Treatment is stopped after 12 weeks if the platelet count does not rise enough to prevent bleeding. The doctor may interrupt treatment or stop it permanently if certain side effects occur.For more information about using Tavlesse, see the package leaflet or contact your doctor or pharmacist.

How does Tavlesse work?

Fostamatinib, the active substance in Tavlesse, blocks the activity of the enzyme spleen tyrosine kinase (SYK). This enzyme is involved in stimulating parts of the immune system. By blocking SYK's activity, fostamatinib reduces the immune system's destruction of platelets, so allowing the platelet count to rise, which reduces the likelihood of excessive bleeding.

What benefits of Tavlesse have been shown in studies?

Tavlesse was found effective in two main studies involving a total of 150 patients with chronic immune thrombocytopenia. The platelet count was stable and above an acceptable level in 17% of patients taking Tavlesse for 24 weeks compared with 2% of patients receiving placebo (a dummy treatment).

What are the risks associated with Tavlesse?

The most common side effects with Tavlesse (which may affect more than 1 in 10 people) are dizziness, high blood pressure, frequent bowel movement and diarrhoea, nausea (feeling sick) and blood tests showing liver changes. Serious side effects (which may affect about 1 in 100 people) are febrile neutropenia (low white blood cell count with fever), diarrhoea, pneumonia (lung infection), and hypertensive crisis (dangerous rise in blood pressure).Women must not take Tavlesse during pregnancy. For the full list of side effects and restrictions, see the package leaflet.

Why is Tavlesse authorised in the EU?

Tavlesse was found modestly effective for patients with immune thrombocytopenia when other treatments had not worked well enough and for whom there is no alternative treatment. Tavlesse can have serious side effects but they can be managed by taking precautions and reducing the dose. The European Medicines Agency therefore decided that Tavlesse'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 Tavlesse?

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


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Tavneos


What is Tavneos and what is it used for?

Tavneos is a medicine used to treat adults with severe, active granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) or microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels. Tavneos is used as part of a combined treatment also including the medicines rituximab or cyclophosphamide.Tavneos contains the active substance avacopan.GPA and MPA are rare, and Tavneos 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 (GPA: 19 November 2014; MPA: 19 November 2014).

How is Tavneos used?

The medicine can only be obtained with a prescription. Treatment should be started and monitored by healthcare professionals experienced in the diagnosis and treatment of GPA or MPA.The medicine is available as capsules and the recommended dose is 30 mg taken by mouth twice daily with meals. The doctor may have to interrupt or stop the treatment in case of certain severe side effects. Patients on Tavneos should avoid grapefruit and grapefruit juice as it can affect the way the medicine works.For more information about using Tavneos, see the package leaflet or contact your doctor or pharmacist.

How does Tavneos work?

The active substance in Tavneos, avacopan, blocks the receptor (target) for a protein in the blood called complement 5a (or C5a), which forms part of the immune system (the body's natural defences).When C5a attaches to its receptor, it activates immune cells called neutrophils, which contribute to the inflammation of small blood vessels in GPA and MPA. By blocking the receptor for C5a, Tavneos is expected to reduce inflammation of blood vessels, thus improving the symptoms of the disease.

What benefits of Tavneos have been shown in studies?

In a study of 330 patients with GPA or MPA, Tavneos was compared with high-dose corticosteroids (other medicines for inflammatory diseases). All patients received standard treatment with either rituximab or a regimen consisting of cyclophosphamide followed by azathioprine. All patients also received additional corticosteroids as needed.After 26 weeks of treatment with Tavneos 72% (120 out of 166) of patients were in complete remission, compared with 70% (115 out of 164) of patients given corticosteroids at high doses for 20 weeks. At week 52, 66% (109 out of 166) of patients on Tavneos and standard therapy were still in remission, compared with 55% (90 out of 164) of patients given corticosteroids and standard therapy.

What are the risks associated with Tavneos?

The most common side effects with Tavneos (which may occur in more than 1 in 10 people) are nausea (feeling sick), headache, decrease in white blood cell count, upper respiratory tract (nose and throat) infection, diarrhoea, vomiting, and nasopharyngitis (inflammation of the nose and throat).The most common serious side effects are liver function abnormalities and pneumonia (infection of the lungs).The full list of side effects and restrictions of Tavneos is presented in the package leaflet.

Why is Tavneos authorised in the EU?

Tavneos was shown to be at least as effective as high-dose corticosteroids in inducing remission in patients with GPA or MPA and to lead to better long-term remission rates. Tavneos' safety profile is acceptable. Abnormalities in patients' liver function were the most serious side effects, and were considered manageable with appropriate guidance presented in the product information. There is a high unmet need for medicines to treat GPA and MPA that will allow doses of corticosteroids to be reduced. The European Medicines Agency therefore decided that Tavneos' 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 Tavneos?

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


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Taxotere


What is Taxotere and what is it used for?

Taxotere is a cancer medicine used to treat the following types of cancer:• breast cancer. Taxotere can be used on its own after other treatments have failed. It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;• non-small cell lung cancer. Taxotere can be used on its own after other treatments have failed. It can also be used with cisplatin (another cancer medicine) in patients who have not received any treatment for their cancer;• prostate cancer, when the cancer has spread to other parts of the body (metastatic). Taxotere is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer). It can also be used with androgen-deprivation therapy when hormonal treatment still works (hormone-sensitive prostate cancer);• gastric adenocarcinoma (a stomach cancer) that has spread in patients who have not received any treatment for their cancer. Taxotere is used with cisplatin and fluorouracil (other cancer medicines);• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Taxotere is used with cisplatin and fluorouracil.Taxotere contains the active substance docetaxel.

How is Taxotere used?

Taxotere can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.Taxotere is given as a 1-hour infusion (drip) into a vein every 3 weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated and theClassified as public by the European Medicines Agencypatient's weight and height. An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxotere infusion.The dose of Taxotere may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.For more information about using Taxotere, see the package leaflet or contact your doctor or pharmacist.

How does Taxotere work?

The active substance in Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes. Docetaxel blocks the ability of cells to break down the internal 'skeleton' that allows them to divide. With the skeleton still in place, the cells cannot divide and they eventually die. Because docetaxel works on dividing cells, it also affects affects non-cancer cells such as blood cells, which can cause side effects.

What benefits of Taxotere have been shown in studies?

Taxotere has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-lungcancer patients, around 2,700 prostate cancer patients, 457 gastric adenocarcinoma patients and 897 head- and neck-cancer patients. In most of these studies, Taxotere was combined with other cancer treatments and compared either with the medicines it is used in combination with or with a combination of different treatments. The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived.Adding Taxotere to other anticancer treatments was effective in all five types of cancer. When used on its own, Taxotere was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or treatment to help patients, but not other cancer medicines) in lung cancer.

What are the risks associated with Taxotere?

The most common side effects with Taxotere (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, white blood cells that fight infection), anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss) and asthenia (weakness). These side effects may be more severe when Taxotere is used with other cancer medicines. For the full list of side effects of Taxotere, see the package leaflet.Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver. For the full list of restrictions, see the package leaflet.

Why is Taxotere authorised in the EU?

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

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

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


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Tecartus


What is Tecartus and what is it used for?

Tecartus is a cancer medicine used to treat:• adults with mantle cell lymphoma (a cancer of B cells, a type of white blood cell) when the cancer has come back after two or more previous treatments, including a type of cancer medicine called a Bruton's tyrosine kinase (BTK) inhibitor;• adults 26 years of age and older with acute lymphoblastic leukaemia (another cancer of B cells) when the cancer has come back or did not respond to previous treatments.These type of B-cell cancers are rare, and Tecartus was designated an 'orphan medicine' (a medicine used in rare diseases) for mantle cell lymphoma on 13 November 2019 and for acute lymphoblastic leukaemia on 19 October 2020.Tecartus contains the active substance brexucabtagene autoleucel, which consists of genetically modified white blood cells.

How is Tecartus used?

Tecartus can only be obtained with a prescription. It must be given to patients by trained doctors in specialist hospitals.Tecartus is prepared using the patient's own white blood cells which are extracted from the blood, genetically modified in the laboratory and then given back to the patient as a single infusion (drip) into a vein. Tecartus must only be given to the patient whose cells were used to make it.Before receiving Tecartus, the patient should have a short course of chemotherapy to clear away their white blood cells, and just before the infusion the patient is given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.A medicine called tocilizumab (or a suitable alternative if tocilizumab is unavailable due to a shortage), and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).Patients should be closely monitored for side effects for 10 days after treatment and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.For more information about using Tecartus, see the package leaflet or contact your doctor or pharmacist.

How does Tecartus work?

Tecartus contains brexucabtagene autoleucel, which consist of the patient's own T cells (a type of white blood cell). These have been modified genetically in the laboratory, so that they make a protein called chimeric antigen receptor (CAR), which helps the T cells attach to a protein on the cancer cells called CD19.When Tecartus is infused to the patient, the modified T cells can then attach to and kill the cancer cells, thereby helping to clear the cancer from the body.

What benefits of Tecartus have been shown in studies?

Mantle cell lymphoma (MCL)A main study, which is currently ongoing, involved 74 adults with MCL whose cancer had come back after at least two previous treatments including a BTK inhibitor. Around 59% of patients (44 out of 74) treated with Tecartus had a complete response (which means they had no signs of the cancer left).This was better than results previously seen in similar patients given other treatments.Acute lymphoblastic leukaemia (ALL)In a main study involving 55 patients, Tecartus was shown to be effective in treating ALL that came back after or did not respond to previous treatments. After about 17 months of treatment, around 71% (39 out of 55) of patients had a complete response (no signs of cancer left) and 56% of all the patients (31 out of 55) had a complete response with their blood counts returning to normal.

What are the risks associated with Tecartus?

In the clinical study, serious side effects occurred in more than half of all patients. The most common serious side effects (which may affect more than 1 in 10 people) are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), encephalopathy (a brain disorder with headache, sleepiness and mental confusion) and infections.

Why is Tecartus authorised in the EU?

Patients with MCL and ALL have poor outcomes, particularly if the cancers come back or did not respond to previous treatments (such as a BTK inhibitor in patients with MCL). Tecartus provides a treatment option for these patients. Although serious side effects occur in most patients and can include cytokine release syndrome, these are manageable if the appropriate measures are in place (see below). The European Medicines Agency therefore decided that Tecartus' benefits are greater than its risks and it can be authorised for use in the EU.Tecartus has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Tecartus?

Since Tecartus has been given a conditional authorisation, the company that markets the medicine will provide to the Agency the final reports of the currently ongoing study on MCL by 2025. The company should also carry out a study on the long-term effects and safety in women, the elderly and patients who are very ill with MCL.To obtain more information on the long-term efficacy and safety of Tecartus in patients with ALL, the company will provide follow-up data from the ongoing study and will conduct an additional study involving patients with ALL.

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

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


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Tecentriq


What is Tecentriq and what is it used for?

Tecentriq is a medicine for treating the following cancers:• urothelial cancer (cancer of the bladder and urinary system);• non-small cell lung cancer (NSCLC) when the disease is early-stage or metastatic (has spread to other parts of the body);• small cell lung cancer (SCLC);• a type of breast cancer known as triple-negative breast cancer;• hepatocellular carcinoma, a cancer that starts in the liver.Tecentriq is used either on its own or in combination with other treatments for cancers that are advanced or have spread to other parts of the body. In some cases, it is used after surgery or after other cancer treatments.The doctor may need to confirm that the cancer cells produce a certain amount of a protein called PDL1, and that particular genetic mutations known to reduce the medicine's effectiveness are not present. For more information about the use of Tecentriq, see the package leaflet.Tecentriq contains the active substance atezolizumab.

How is Tecentriq used?

Tecentriq is given as an infusion (drip) into a vein every 2, 3 or 4 weeks. Depending on the type of cancer, patients are treated either for one year or for as long as they benefit from treatment, unless they have unmanageable side effects. The doctor may stop treatment if the patient has certain side effects involving the immune system (the body's defence system), including inflammation of various body organs or endocrine (glandular) disorders. For more information about using Tecentriq, see the package leaflet or contact your doctor or pharmacist.Tecentriq can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.

How does Tecentriq work?

The active substance in Tecentriq, atezolizumab, is a monoclonal antibody (a type of protein) designed to attach to a protein called PD-L1, which is present on many cancer cells.PD-L1 switches off immune cells that would otherwise attack cancer cells. By attaching to PD-L1, Tecentriq reduces its effects and so increases the immune system's ability to attack cancer cells and thereby slows down progression of the disease.

What benefits of Tecentriq have been shown in studies?

Urothelial cancerTecentriq reduces tumours in patients with urothelial cancer that is advanced or has spread. In a study of 429 patients, the cancer shrank or was eliminated after Tecentriq treatment in 23% of patients who were not eligible for platinum chemotherapy and in 16% of patients who had previously had platinum chemotherapy.In another study involving 931 patients with urothelial cancer, those given Tecentriq lived slightly longer (8.6 months) than patients given chemotherapy (8 months) although the difference could be due to chance. Response was seen even in patients whose cancer cells did not produce much PD-L1.Lung cancerNon-small cell lung cancerIn patients with non-small cell lung cancer that is advanced or has spread, Tecentriq is more effective than docetaxel (another cancer medicine) at prolonging patients' lives. In one main study of 850 patients, those given Tecentriq lived for 14 months on average while those given docetaxel lived for 10 months. In a second study of 287 patients, patients on Tecentriq lived for 13 months on average compared with 10 months for patients on docetaxel.In another main study of 1,202 patients with advanced non-small cell lung cancer which has spread and who had not received chemotherapy before, patients given Tecentriq together with paclitaxel, carboplatin and bevacizumab (other cancer medicines) lived on average for 8.4 months without their disease getting worse while those given paclitaxel, carboplatin and bevacizumab lived on average for 6.8 months without their disease getting worse. Overall, patients given Tecentriq with the other medicines lived for 19.8 months on average compared with 14.9 months for patients given the medicines without Tecentriq.Another study investigated the effect of Tecentriq in 679 previously untreated patients with non-small cell lung cancer (NSCLC) who did not have a type of cancer known as EGFR mutant or ALK-positive NSCLC. Patients lived on average for 18.6 months when they were given Tecentriq with carboplatin plus nab-paclitaxel compared with 13.9 months when given the combination without Tecentriq. In addition, patients lived for about 7 months without their disease getting worse when they received the Tecentriq combination compared with 5.5 months without Tecentriq.In a further study in 205 patients with metastatic non-small cell lung cancer who had not received chemotherapy before, patients treated with Tecentriq lived for 20.2 months on average compared with 14.7 months for those who received platinum-based chemotherapy and either pemetrexed or gemcitabine.Tecentriq was shown to be effective in patients with early-stage NSCLC without EGFR or ALK mutations in which more than 50% of the cancer cells presented PD-L1 on their surface, and who had undergone surgery to completely remove the cancer before receiving platinum-based therapy. After approximately 32 months, around 77% of patients who received Tecentriq (82 out of 106) had no sign of the cancer coming back, compared with 56% (58 out of 103) of patients who received standard cancer treatments. At the time of authorisation, no benefit was observed in patients with cancer cells that presented lower levels of PD-L1 on their surface.Small cell lung cancerIn a study of 403 patients with the generally more aggressive small cell lung cancer, patients lived for 12.3 months on average when Tecentriq was added to carboplatin plus etoposide, compared with 10.3 months when placebo (a dummy treatment) was added instead. In addition, patients given the Tecentriq combination lived for 5.2 months on average without their disease getting worse compared with 4.3 months for patients who were not given Tecentriq.Breast cancerA study of 902 patients with a type of breast cancer known as triple-negative breast cancer looked at the effect of combining Tecentriq with nab-paclitaxel. Patients whose cancer produced the PD-L1 protein up to a certain level lived for an average of 25 months on the Tecentriq plus nab-paclitaxel combination compared with 18 months when given placebo plus nab-paclitaxel. Patients in the Tecentriq group also lived for longer without their disease getting worse (7.5 months versus 5.3).Hepatocellular carcinomaA study involved 501 patients with hepatocellular carcinoma that had spread and had not been treated previously. Patients treated with Tecentriq in combination with bevacizumab lived on average for 6.8 months without their disease getting worse, compared to 4.3 months for patients treated with sorafenib.

What are the risks associated with Tecentriq?

The most common side effects with Tecentriq when used on its own (which may affect more than 1 in 10 people) are tiredness, reduced appetite, nausea (feeling sick), vomiting, cough, difficulty breathing, diarrhoea, rash, fever, headache, pain in the back and joints, weakness, itching and urinary tract infection.The most common side effects with Tecentriq when used with other cancer medicines (which may affect more than 2 in 10 people) are peripheral neuropathy (nerve damage in the hands and feet), nausea, anaemia (low red blood cell counts), neutropenia (low white blood cell counts), alopecia (loss of hair), thrombocytopenia (low platelet counts), rash, tiredness, constipation, reduced appetite and diarrhoea.For the full list of side effects and restrictions, see the package leaflet.

Why is Tecentriq authorised in the EU?

In urothelial cancer, Tecentriq has been shown to reduce tumour size in patients who have been treated with platinum chemotherapy or who are not eligible for such treatment. Tecentriq can also prolong how long patients with lung cancer, triple-negative breast cancer and hepatocellular carcinoma live.Tecentriq's side effects when used alone are less troublesome than standard chemotherapy treatments. When Tecentriq is used in combination with other cancer medicines, the side effects are more severe but are considered manageable.The European Medicines Agency therefore decided that Tecentriq'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 Tecentriq?

The company that markets Tecentriq is providing an educational programme for patients and healthcare professionals to explain that serious immune-related side effects can occur during treatment and what they should do to minimise risks. The company is also carrying out studies to provide more data on the effectiveness of Tecentriq in urothelial cancer and on the medicine's safety.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tecentriq have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tecentriq are continuously monitored. Side effects reported with Tecentriq are carefully evaluated and any necessary action taken to protect patients.


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Tecfidera


What is Tecfidera and what is it used for?

Tecfidera is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults and children from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Tecfidera contains the active substance dimethyl fumarate.

How is Tecfidera used?

Tecfidera can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.Tecfidera is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal (stomach and gut) problems.For more information about using Tecfidera, see the package leaflet or contact your doctor or pharmacist.

How does Tecfidera work?

In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. The active substance, dimethyl fumarate, is thought to work by activating a protein called 'Nrf2' that regulates certain genes that produce 'antioxidants' involved in protecting cells from damage. Dimethyl fumarate, has been shown to reduce inflammation and modulate the activity of the immune system.

What benefits of Tecfidera have been shown in studies?

Tecfidera has been shown to reduce the risk of relapses and how often they occur in adults with relapsing-remitting MS. In a main study involving 1,234 adults, the proportion of patients who experienced a relapse over the course of two years was significantly lower with Tecfidera treatment than with placebo (a dummy treatment): 27% versus 46%.In a second main study involving 1,417 adults, patients were given Tecfidera, placebo or another medicine for MS, glatiramer acetate. This study showed Tecfidera to be more effective than placebo in reducing the number of relapses over the course of two years: the number of relapses per patient per year was around 0.2 with Tecfidera compared with 0.4 with placebo. The number of relapses per patient per year for glatiramer acetate was 0.3.A main study involving 150 children and adolescents aged 10 to 17 years compared the effects of Tecfidera with interferon beta-1a (another MS medicine). After two years of treatment, around 13% of children taking Tecfidera had no new or newly enlarged lesions (damaged areas) in the brain, compared with around 3% of children in the interferon group. Since there were very few 10- to 12year-old children in the study, it was not possible to determine the safety of Tecfidera in these young patients, and use of the medicine is therefore recommended from the age of 13.

What are the risks associated with Tecfidera?

The most common side effects with Tecfidera (which may affect more than 1 in 10 people) are flushing (reddening of skin) and gastrointestinal problems (such as diarrhoea, nausea, and pain in the abdominal area). These side effects tend to start early during treatment, usually in the first month, and may continue intermittently throughout treatment.Tecfidera must not be used in patients who have or might have progressive multifocal leukoencephalopathy (PML), a serious brain infection that has been associated with some MS medicines.For the full list of side effects and restrictions with Tecfidera, see the package leaflet.

Why is Tecfidera authorised in the EU?

Tecfidera has been shown to be effective in reducing the risk of relapses in adults with relapsingremitting MS and how often they occur, and in reducing the risk of new lesions appearing or existing lesions becoming larger in children and adolescents from 13 years of age. The main risks identified with Tecfidera are considered to be manageable and include flushing and gastrointestinal problems (the most common side effects), as well as reduced levels of white blood cells, and protein in the urine.The European Medicines Agency therefore decided that Tecfidera'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 Tecfidera?

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


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Tecovirimat Siga


What is Tecovirimat SIGA and what is it used for?

Tecovirimat SIGA is a medicine to treat smallpox, monkeypox and cowpox, three infections caused by viruses belonging to the same family (orthopoxviruses). It is also used to treat complications that can happen following vaccination against smallpox. Tecovirimat SIGA is used in adults and children weighing at least 13 kg.It contains the active substance tecovirimat.

How is Tecovirimat SIGA used?

The medicine can only be obtained with a prescription.Tecovirimat SIGA is available as capsules to be taken by mouth, and the dose depends on bodyweight.Tecovirimat treatment should be initiated as soon as possible after diagnosis.For more information about using Tecovirimat SIGA, see the package leaflet or contact your doctor or pharmacist.

How does Tecovirimat SIGA work?

Tecovirimat SIGA works by interfering with a protein called VP37 that is found on the surface of orthopoxviruses, including smallpox, monkeypox and cowpox. By interacting with this protein, the medicine prevents the viruses from reproducing normally, slowing down the spread of infection.

What benefits of Tecovirimat SIGA have been shown in studies?

Because smallpox, monkeypox and cowpox are either eradicated (smallpox) or occur sporadically in the EU, studies to assess the effectiveness of Tecovirimat SIGA in infected people could not be carried out.The effectiveness of Tecovirimat SIGA was therefore evaluated based on studies in animals infected with lethal doses of orthopoxviruses, on studies on the medicine's effects in the human body, and on the way the medicine is absorbed, modified and removed from the body in humans and animals (pharmacodynamics and pharmacokinetics studies).Studies in animals who had received lethal doses of either monkeypox or rabbitpox viruses showed that treatment with Tecovirimat SIGA for 14 days significantly increased survival rates: when treatment started either 4 or 5 days after infection, between 80 and 100% of the animals that were treated with Tecovirimat SIGA survived. No animals in the placebo groups survived. The survival rate was 50% when treatment started 6 days after the infection.The dose that is needed in humans to ensure that Tecovirimat SIGA will work as expected was determined based on comparative pharmacokinetics and pharmacodynamics studies carried out in animals and in humans.

What are the risks associated with Tecovirimat SIGA?

The most common side effects with Tecovirimat SIGA are headache (which may affect more than 1 in 10 people) and nausea (feeling sick) (which may affect up to 1 in 10 people).For the full list of restrictions, see the package leaflet.

Why is Tecovirimat SIGA authorised in the EU?

The European Medicines Agency considered that Tecovirimat SIGA is effective at reducing mortality caused by smallpox, monkeypox and cowpox, based on animal studies. While the safety of the medicine was assessed in non-infected people, the side effects of Tecovirimat SIGA are expected to be similar in infected people and are considered acceptable. The European Medicines Agency therefore decided that Tecovirimat SIGA's benefits are greater than its risks and it can be authorised for use in the EU.There are no other treatments authorised for the monkeypox and cowpox infections, which although rare can be fatal. In addition, while smallpox has been eradicated, this is an extremely serious infection, for which no treatment exists should an outbreak occur.Tecovirimat SIGA has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about Tecovirimat SIGA due to the rarity of the diseases. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Tecovirimat SIGA?

Since Tecovirimat SIGA has been authorised under exceptional circumstances, the company that markets Tecovirimat SIGA will provide data on the effectiveness and safety of the medicine in patients given the medicine should an outbreak of smallpox occur.

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

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


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Tecvayli


What is Tecvayli and what is it used for?

Tecvayli is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It can be used in patients who have received at least three previous treatments for their cancer, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.Tecvayli contains the active substance teclistamab.

How is Tecvayli used?

The medicine can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma, in a location with appropriate medical support to manage severe side effects such as cytokine release syndrome (a potentially lifethreatening condition that causes fever, vomiting, shortness of breath, headache and low bloodpressure; see risks section below).Tecvayli is given as an injection under the skin. The recommended dose is based on the patient's body weight. Treatment starts with injections on days 1, 3 and 5 at increasing doses (so-called step-up dosing). One to three hours before receiving these injections, patients are given medicines to reduce the risk of developing cytokine release syndrome. After step-up dosing, patients are given maintenance doses once a week. Treatment can continue until the disease gets worse or the patient experiences unacceptable side effects.For more information about using Tecvayli, see the package leaflet or contact your doctor or pharmacist.

How does Tecvayli work?

The active substance in Tecvayli is teclistamab, an antibody (a type of protein) that is designed to recognise and attach to two targets simultaneously: the B cell maturation antigen (BCMA) on myeloma cells and CD3 on the surface of T cells (cells in the immune system). By attaching to these target proteins, this medicine brings the cancer cells and T cells together. This activates the T cells, which then kill the multiple myeloma cells.

What benefits of Tecvayli have been shown in studies?

The benefits of Tecvayli have been investigated in an ongoing study involving 165 patients with multiple myeloma who had received at least three prior treatments (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and whose disease had not improved (refractory) or had come back (relapsed) after the last treatment. The study did not compare Tecvayli with other medicines or placebo (a dummy treatment). In this study, 63% (104 out of 165) of patients responded to treatment with Tecvayli and they lived for an average of 18 months without their disease getting worse.

What are the risks associated with Tecvayli?

The most common side effects with Tecvayli (which may affect more than 1 in 10 people) are hypogammaglobulinaemia (low immunoglobulin or antibody levels in the blood, which increases the risk of infection), cytokine release syndrome, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), anaemia (low levels of red blood cells or haemoglobin), pain in the muscles and bones, tiredness, thrombocytopenia (low levels of blood platelets, components that help the blood to clot), injection site reactions, upper respiratory tract (nose and throat) infection, lymphopenia (low levels of lymphocytes, a type of white blood cell), diarrhoea, pneumonia (infection of the lungs), nausea (feeling sick), fever, headache, cough, constipation and pain.The most common serious side effects are pneumonia, COVID-19, cytokine release syndrome, sepsis (blood poisoning; when bacteria and their toxins circulate in the blood, leading to organ damage), fever, pain in the muscles and bones, acute kidney injury, diarrhoea, cellulitis (inflammation of deep skin tissue), hypoxia (lack of oxygen in body tissues), febrile neutropenia (low levels of neutrophils with fever), and encephalopathy (a brain disorder).For the full list of side effects and restrictions of Tecvayli, see the package leaflet.

Why is Tecvayli authorised in the EU?

At the time of approval, treatment options were limited for patients with multiple myeloma once they no longer respond to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Tecvayli addressed a medical need in these patients and showed a clinically relevant treatment effect, although the lack of a comparator, the short duration of the follow-up of patients within the main study and the small number of patients involved in this study limited the evaluation of the benefits and risks associated with its use.Tecvayli has therefore been given 'conditional authorisation'. This means that that the European Medicines Agency decided that the benefits of Tecvayli are greater than its risks, but the company will have to provide additional evidence after authorisation.Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the European Medicines Agency will review any new information that becomes available until data become comprehensive and this overview will be updated as necessary.

What information is still awaited for Tecvayli?

Since Tecvayli has been given conditional authorisation, the company that markets this medicine is required to submit the final results of the ongoing study in patients with multiple myeloma who weretreated with Tecvayli. In addition, they will have to provide data from a study that compares the effectiveness of Tecvayli in combination with daratumumab (another cancer medicine) with that of other treatments currently authorised for use in adults with relapsed or refractory multiple myeloma.

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

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


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Tegsedi


What is Tegsedi and what is it used for?

Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves.Tegsedi is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).hATTR is rare, and Tegsedi was designated an 'orphan medicine' (a medicine used in rare diseases) on 26 March 2014. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

How is Tegsedi used?

Tegsedi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with hATTR.The medicine is available as a solution for injection under the skin in pre-filled syringes (284 mg). The recommended dose is one injection once a week, given under the skin in the belly, upper thigh or upper arm. The first injection should be given under the supervision of a qualified healthcare professional, and patients or carers can give the subsequent injections after receiving appropriate training.As Tegsedi can cause a reduction in the number of platelets in the blood (posing a risk of bleeding), blood platelet counts need to be monitored during treatment with Tegsedi, and the dose of the medicine and how often it is given adjusted accordingly.For more information about using Tegsedi, see the package leaflet or contact your doctor or pharmacist.

How does Tegsedi work?

In patients with hATTR, a protein called transthyretin which circulates in the blood is defective and breaks easily. The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.The active substance in Tegsedi, inotersen, is an 'antisense oligonucleotide', a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin. This reduces production of transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.

What benefits of Tegsedi have been shown in studies?

In one main study involving 173 hATTR patients with stage 1 or 2 nerve damage, Tegsedi was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease. The main measures of effectiveness were the changes in the patients' nerve damage and quality of life, as measured using standard scales called 'mNIS+7' and 'Norfolk QoL-DN' respectively. After 15 months of treatment, the mNIS+7 score, used for assessing nerve damage, worsened by a lesser extent with Tegsedi (around 11 points) than with placebo (around 25 points). Quality of life, measured by the Norfolk QoL-DN score, worsened by around 4 points in patients treated with Tegsedi, compared with around 13 points in those on placebo.

What are the risks associated with Tegsedi?

The most common side effects with Tegsedi (which may affect more than 1 in 10 people) are reactions at the site of injection, nausea (feeling sick), low level of red blood cells, headache, fever, peripheral oedema (swelling, especially of the ankles and feet), chills, vomiting and low blood platelet counts which can lead to bleeding and bruising. For the full list of side effects of Tegsedi, see the package leaflet.Tegsedi must not be used by patients with low platelet counts (less than 100x109/l), and by patients with severe kidney or liver problems. For the full list of restrictions, see the package leaflet.

Why is Tegsedi authorised in the EU?

Tegsedi was shown to be effective in the treatment of stage 1 or stage 2 nerve damage in patients with hATTR; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair). In light of the unmet medical need, the safety profile of Tegsedi was considered acceptable and the risks to be manageable with specific monitoring, dose reduction and stopping rules.The European Medicines Agency therefore decided that Tegsedi'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 Tegsedi?

The company that markets Tegsedi will provide an alert card for patients with information about the safety of the medicine and how to manage side effects.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tegsedi have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tegsedi are continuously monitored. Side effects reported with Tegsedi are carefully evaluated and any necessary action taken to protect patients.


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Telmisartan Actavis


What is Telmisartan Actavis?

Telmisartan Actavis is a medicine that contains the active substance telmisartan. It is available as tablets (20 mg; 40 and 80 mg).Telmisartan Actavis is a 'generic medicine'. This means that Telmisartan Actavis is similar to a 'reference medicine' already authorised in the European Union (EU) called Micardis. For more information on generic medicines, see the question-and-answer document here.

What is Telmisartan Actavis used for?

Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults. 'Essential' means that the hypertension has no obvious cause.Telmisartan Actavis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).The medicine can only be obtained with a prescription.

How is Telmisartan Actavis used?

For the treatment of essential hypertension, the usual recommended dose of Telmisartan Actavis is 40 mg once a day, but some patients may benefit from using 20 mg once a day. If the target bloodpressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient's blood pressure closely when starting Telmisartan Actavis, and may decide to adjust the patient's blood pressure-lowering medication. Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.

How does Telmisartan Actavis work?

The active substance in Telmisartan Actavis, telmisartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.

How has Telmisartan Actavis been studied?

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

What are the benefits and risks of Telmisartan Actavis?

Because Telmisartan Actavis 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 has Telmisartan Actavis been approved?

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


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Telmisartan Teva Pharma


What is Telmisartan Teva Pharma?

Telmisartan Teva Pharma is a medicine that contains the active substance telmisartan. It is available as tablets (20 mg, 40 mg and 80 mg).Telmisartan Teva Pharma is a 'generic medicine'. This means that Telmisartan Teva Pharma is similar to a 'reference medicine' already authorised in the European Union (EU) called Micardis. For more information on generic medicines, see the question-and-answer document here.

What is Telmisartan Teva Pharma used for?

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure) in adults. 'Essential' means that the hypertension has no obvious cause.Telmisartan Teva Pharma is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).The medicine can only be obtained with a prescription.

How is Telmisartan Teva Pharma used?

For the treatment of essential hypertension, the usual recommended dose of Telmisartan Teva Pharma is 40 mg once a day, but some patients may benefit from using a 20-mg dose. If the target bloodpressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient's blood pressure closely when starting Telmisartan Teva Pharma, and may decide to adjust the patient's blood pressure-lowering medication. Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day

How does Telmisartan Teva Pharma work?

The active substance in Telmisartan Teva Pharma, telmisartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems

How has Telmisartan Teva Pharma been studied?

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

What are the benefit and risk of Telmisartan Teva Pharma?

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

Why has Telmisartan Teva Pharma been approved?

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


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Telzir


What is Telzir and what is it used for?

Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).Telzir is used in combination with ritonavir and other HIV medicines. It contains the active substance fosamprenavir.

How is Telzir used?

Telzir is available as tablets (700 mg) and as an oral suspension (50 mg/ml) to be taken by mouth. The recommended dose for adults (aged 18 years or over) and for patients aged between 6 and 18 years who weigh more than 39 kg is 700 mg twice a day. In patients aged between 6 and 18 years who weigh between 25 and 39 kg, the dose depends on body weight. There is no recommended dose for patients below 18 years who weigh less than 25 kg.Telzir tablets can be taken with or without food. The oral suspension should be taken without food in adults, but in younger patients it should be taken with food in order to hide the taste and help them stick to treatment. In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day. In younger patients, the dose of ritonavir depends on body weight.Adults with liver problems should take a reduced dose of Telzir and be closely monitored for side effects and their response to treatment.For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Telzir once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection. The medicine can only be obtained with a prescription. For more information about using Telzir, see the package leaflet or contact your doctor or pharmacist.

How does Telzir work?

The active substance in Telzir, fosamprenavir, is a 'prodrug' of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body. Amprenavir, which was previously available in the EU, . blocks an enzyme that is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Telzir does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.Ritonavir, another protease inhibitor, is used with Telzir as a 'booster'. It slows down the rate at which amprenavir is broken down, helping to increase levels of amprenavir in the blood.

What benefits of Telzir have been shown in studies?

Telzir has been studied in three main studies involving 1,862 adults. Two of the studies in previously untreated patients showed that Telzir in combination with other antiviral medicines was as effective as comparator medicines.In one study, after 48 weeks of treatment, 69% of previously untreated adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml (considered a low viral load). Similar results were seen in the other study comparing ritonavir-boosted Telzir with ritonavir-boosted lopinavir, with around three-quarters of both groups of previously untreated patients having viral loads below 400 copies/ml.In a third study in patients who had been treated before, Telzir was less effective than the comparator medicine lopinavir, with patients taking lopinavir having larger reductions in viral loads over the first 48 weeks.Patients in these three adult studies also took two reverse-transcriptase inhibitors (another type of antiviral medicine) in addition to Telzir or the medicine Telzir was being compared with.A similar benefit was also seen in one main study including 57 children aged between 2 and 18 years. However, there were too few patients aged below 6 years to support the use of Telzir in this age group.

What are the risks associated with Telzir?

The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of cholesterol (a type of fat) in the blood. Similar side effects are seen in younger patients. For the full list of side effects of Telzir, see the package leaflet.Telzir should not be used in people who are hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir. Telzir must not be used in patients who are taking lurasidone (for schizophrenia and bipolar disorder), paritaprevir (for hepatitis C), simvastatin or lovastatin (for lowering blood cholesterol), rifampicin (for tuberculosis), St John's wort (a herbal preparation for depression and anxiety), or certain medicines that are broken down in the same way as Telzir or ritonavir as Telzir may affect their blood levels. As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir.

Why is Telzir authorised in the EU?

The European Medicines Agency concluded that Telzir, which contains a prodrug of amprenavir, is as effective as comparator medicines in reducing viral load. Although the Agency noted that the use of ritonavir-boosted Telzir had not been studied sufficiently in heavily pretreated patients and that studies carried out in children did not compare Telzir with a comparator medicine, it decided that Telzir'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 Telzir?

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


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Temodal


What is Temodal?

Temodal is a medicine that contains the active substance temozolomide. It is available as capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg) and as a powder to be made up into a solution for infusion (drip into a vein).

What is Temodal used for?

Temodal is an anticancer medicine. It is used to treat malignant glioma (brain tumours) in the following groups of patients:• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). Temodal is used first with radiotherapy and then on its own;• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temodal is used on its own in these patients.The medicine can only be obtained with a prescription.

How is Temodal used?

Treatment with Temodal should be prescribed by a doctor with experience in the treatment of brain tumours.The dose of Temodal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temodal is being used alone or with radiotherapy, and how the patient responds to treatment. Temodal capsules should be taken whole without food. If the solution for infusion is used, it should be given over a period of 90 minutes. Patients may also need to take medicines to prevent vomiting before taking Temodal.For full details, see the summary of product characteristics (also part of the EPAR).

How does Temodal work?

The active substance in Temodal, temozolomide, belongs to a group of anticancer medicines called alkylating agents. In the body, temozolomide is converted to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.

How has Temodal been studied?

Temodal capsules have been studied in four main studies.The first study compared the effectiveness of Temodal and radiotherapy with that of radiotherapy on its own in 573 patients with newly diagnosed glioblastoma multiforme.The other three main studies involved patients with malignant glioma that had come back or got worse after previous treatment. Two of these studies involved patients with glioblastoma multiforme: one looked at the effects of Temodal in 138 patients and the other compared Temodal with procarbazine (another anticancer medicine) in 225 patients. The final study looked at the safety and effectiveness of Temodal in the treatment of 162 patients with anaplastic astrocytoma who were in their first relapse.The main measures of effectiveness were how long the patients survived or the length of time before the patient's cancer started to get worse.A further two studies were carried out in a total of 35 patients with brain tumours to show that the capsules and solution for infusion produce the same levels of temozolomide in the blood.

What benefit has Temodal shown during the studies?

In the study of newly diagnosed glioblastoma multiforme, patients survived for an average of 14.6 months when they received Temodal and radiotherapy, compared with 12.1 months with radiotherapy alone.In the comparative study of glioblastoma multiforme that had come back or got worse after previous treatment, it took an average of 2.9 months until the cancer got worse in patients taking Temodal, compared with 1.9 months in the patients taking procarbazine. In anaplastic astrocytoma, it took an average of 5.4 months for the cancer to get worse in patients taking Temodal.

What is the risk associated with Temodal?

The most common side effects with Temodal (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, constipation, loss of appetite, alopecia (hair loss), headache, fatigue (tiredness), convulsions (fits), rash, neutropenia or lymphopenia (low white blood cell counts), and thrombocytopenia (low blood platelet counts). Patients receiving the solution for infusion may alsohave injection site reactions, such as pain, irritation, itching, warmth, swelling and redness, as well as bruising. For the full list of all side effects reported with Temodal, see the package leaflet.Temodal must not be used in people who are hypersensitive (allergic) to temozolomide, any of the other ingredients or dacarbazine (another anticancer medicine). Temodal must not be used in patients with severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells).

Why has Temodal been approved?

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


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Temomedac


What is Temomedac?

Temomedac is a cancer medicine that contains the active substance temozolomide. It is available as capsules (5, 20, 100, 140, 180 and 250 mg).Temomedac is a 'generic medicine'. This means that Temomedac is similar to a 'reference medicine' already authorised in the European Union (EU) called Temodal. For more information on generic medicines, see the question-and-answer document here.

What is Temomedac used for?

Temomedac is used to treat malignant glioma (brain tumours) in the following groups of patients:• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). Temomedac is used first with radiotherapy and then on its own;• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temomedac is used on its own in these patients.The medicine can only be obtained with a prescription.

How is Temomedac used?

Treatment with Temomedac should be prescribed by a doctor with experience in the treatment of brain tumours.The dose of Temomedac depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temomedac is being used alone or with other treatments, and how the patient responds to treatment.Temomedac capsules should be taken whole without food. Patients may also need to take medicines to prevent vomiting before taking Temomedac.For full details, see the summary of product characteristics (also part of the EPAR).

How does Temomedac work?

The active substance in Temomedac, temozolomide, belongs to a group of cancer medicines called alkylating agents. In the body, temozolomide is converted to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.

How has Temomedac been studied?

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

What are the benefits and risks of Temomedac?

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

Why has Temomedac been approved?

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


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Temozolomide Accord


What is Temozolomide Accord?

Temozolomide Accord is a cancer medicine that contains the active substance temozolomide. It is available as capsules (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).Temozolomide Accord is a 'generic medicine'. This means that Temozolomide Accord is similar to a 'reference medicine' already authorised in the European Union (EU) called Temodal. For more information on generic medicines, see the question-and-answer document here.

What is Temozolomide Accord used for?

Temozolomide Accord is used to treat malignant glioma (brain tumours) in the following groups of patients:• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). Temozolomide Accord is used first with radiotherapy and then on its own;• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temozolomide Accord is used on its own in these patients.The medicine can only be obtained with a prescription.

How is Temozolomide Accord used?

Treatment with Temozolomide Accord should be prescribed by a doctor with experience in the treatment of brain tumours.1 Previously known as Temozolomide Hospira.The dose of Temozolomide Accord depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Accord is being used alone or with other treatments, and how the patient responds to treatment. Temozolomide Accord should be taken without food. Patients may also need to take medicines to prevent vomiting before taking Temozolomide Accord.For full details, see the summary of product characteristics (also part of the EPAR).

How does Temozolomide Accord work?

The active substance in Temozolomide Accord, temozolomide, belongs to a group of cancer medicines called alkylating agents. In the body, temozolomide is converted to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.

How has Temozolomide Accord been studied?

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

What are the benefit and risk of Temozolomide Accord?

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

Why has Temozolomide Accord been approved?

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


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Temozolomide Sun


What is Temozolomide Sun?

Temozolomide Sun is a medicine that contains the active substance temozolomide. It is available as capsules (5, 20, 100, 140, 180 and 250 mg).Temozolomide Sun is a 'generic medicine'. This means that Temozolomide Sun is similar to a 'reference medicine' already authorised in the European Union (EU) called Temodal. For more information on generic medicines, see the question-and-answer document here.

What is Temozolomide Sun used for?

Temozolomide Sun is an anticancer medicine. It is used to treat malignant glioma (brain tumours) in the following groups of patients:• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). Temozolomide Sun is used first with radiotherapy and then on its own;• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temozolomide Sun is used on its own in these patients.The medicine can only be obtained with a prescription.

How is Temozolomide Sun used?

Treatment with Temozolomide Sun should be prescribed by a doctor with experience in the treatment of brain tumours.The dose of Temozolomide Sun depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Sun is being used alone or with other treatments, and how the patient responds to treatment. Temozolomide Sun should be taken without food.Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver problems or with kidney problems.For full details, see the summary of product characteristics (also part of the EPAR).

How does Temozolomide Sun work?

The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents. In the body, temozolomide is converted to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.

How has Temozolomide Sun been studied?

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

What are the benefits and risks of Temozolomide Sun?

Because Temozolomide Sun 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 has Temozolomide Sun been approved?

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


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Temozolomide Teva


What is Temozolomide Teva?

Temozolomide Teva is a medicine that contains the active substance temozolomide. It is available as capsules (5, 20, 100, 140, 180 and 250 mg).Temozolomide Teva is a 'generic medicine'. This means that Temozolomide Teva is similar to a 'reference medicine' already authorised in the European Union (EU) called Temodal. For more information on generic medicines, see the question-and-answer document here.

What is Temozolomide Teva used for?

Temozolomide Teva is a cancer medicine. It is used to treat malignant glioma (brain tumours) in the following groups of patients:• adults with newly diagnosed glioblastoma multiforme (an aggressive type of malignant glioma). Temozolomide Teva is used first with radiotherapy and then on its own;• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temozolomide Teva is used on its own in these patients.The medicine can only be obtained with a prescription.

How is Temozolomide Teva used?

Treatment with Temozolomide Teva should be prescribed by a doctor with experience in the treatment of brain tumours.The dose of Temozolomide Teva depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Teva is being used alone or with other treatments, and how the patient responds to treatment. Temozolomide Teva should be taken without food.Patients may also need to take medicines to prevent vomiting before taking Temozolomide Teva. Temozolomide Teva should be used with caution in patients with severe liver problems or with kidney problems.For full details, see the summary of product characteristics (also part of the EPAR).

How does Temozolomide Teva work?

The active substance in Temozolomide Teva, temozolomide, belongs to a group of cancer medicines called alkylating agents. In the body, temozolomide is converted to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.

How has Temozolomide Teva been studied?

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

What are the benefits and risks of Temozolomide Teva?

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

Why has Temozolomide Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Temozolomide Teva has been shown to have comparable quality and to be bioequivalent to Temodal. Therefore, the CHMP's view was that, asfor Temodal, the benefit outweighs the identified risk. The Committee recommended that Temozolomide Teva be given marketing authorisation.


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Tenkasi


What is Tenkasi and what is it used for?

Tenkasi is an antibiotic used in adults and children from 3 months of age to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections. It contains the active substance oritavancin.

How is Tenkasi used?

Tenkasi is given as a single infusion (drip) into a vein. The medicine can only be obtained with a prescription. Before using Tenkasi, doctors should consider official guidance on the appropriate use of antibiotics.For more information about using Tenkasi, see the package leaflet or contact your healthcare provider.

How does Tenkasi work?

The active substance in Tenkasi, oritavancin, is a type of antibiotic called a glycopeptide. It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria. Tenkasi has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.

What benefits of Tenkasi have been shown in studies?

Tenkasi, given as a single infusion, was compared with a 7- to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections. These also included infections caused by MRSA.In both studies, the main measure of effectiveness was the number of patients who responded within 3 days of starting treatment with an improvement in their skin in the infected area, lack of fever and noneed for additional antibiotic. The study also looked at the number of patients whose infection was cured after treatment.Tenkasi was at least as effective as vancomycin at treating the infection: 80.1% of patients treated with Tenkasi in the first study and 82.3% in the second study responded to treatment, compared with 82.9% and 78.9% respectively of patients treated with vancomycin. In addition, 82.7% of patients treated with Tenkasi in the first study and 79.6% in the second study were cured, compared with80.5% and 80.0% respectively of patients treated with vancomycin.An additional study involving 38 children from 3 months to less than 18 years of age showed that when given at the recommended dose in children of this age range, Tenkasi led to blood levels of the active substance, oritavancin, similar to those seen in adults.

What are the risks associated with Tenkasi?

For the full list of side effects and restrictions with Tenkasi, see the package leaflet.The most common side effects with Tenkasi (which may affect 5 people or more in 100) are nausea (feeling sick), hypersensitivity (allergy) reactions or reactions at the site of infusion and headache. The most common side effects that resulted in treatment being stopped were cellulitis and osteomyelitis (bone infection).Patients who have received Tenkasi must not be given an infusion of unfractionated heparin (a medicine used to prevent blood clots) for 120 hours after the infusion of Tenkasi. For the full list of side effects and restrictions with Tenkasi, see the package leaflet.

Why is Tenkasi authorised in the EU?

The European Medicines Agency noted that Tenkasi, which can be given as a single dose, could be a valuable alternative treatment option for acute bacterial infections of the skin and of skin structures. .Tenkasi's safety profile overall is similar to that of other glycopeptides, although some side effects occurred more frequently such as abscesses and bone infections. EMA considered that these side effects were manageable and adequately addressed in the product information.The European Medicines Agency concluded that Tenkasi'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 Tenkasi?

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


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Tenofovir Disoproxil Mylan


What is Tenofovir disoproxil Mylan and what is it used for?

Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS). Tenofovir disoproxil Mylan is used in combination with other HIV medicines. In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI). For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age. It is used in patients with liver damage but whose liver is still working properly (compensated liver disease). In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil. It is a 'generic medicine'. This means that it is similar to a 'reference medicine' already authorised in the European Union (EU)called Viread. For more information on generic medicines, see the question-and-answer document here.

How is Tenofovir disoproxil Mylan used?

Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B.Tenofovir disoproxil Mylan is available as tablets (245 mg) to be taken by mouth. The usual dose is one tablet taken once a day with food. The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function. For more information, see the package leaflet.

How does Tenofovir disoproxil Mylan work?

The active substance in this medicine, tenofovir disoproxil, is a 'prodrug' that is converted into tenofovir in the body.Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI). In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected. Tenofovir disoproxil Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called 'DNA polymerase', which is involved in the formation of viral DNA. Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.

How has Tenofovir disoproxil Mylan been studied?

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

What are the benefits and risks of Tenofovir disoproxil Mylan?

Because Tenofovir disoproxil 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 Tenofovir disoproxil Mylan approved?

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

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

The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.


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Tenofovir Disoproxil Zentiva


What is Tenofovir disoproxil Zentiva and what is it used for?

Tenofovir disoproxil Zentiva is an antiviral medicine used to treat patients aged 12 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS). Tenofovir disoproxil Zentiva is used in combination with other HIV medicines. In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI). For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Zentiva once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.Tenofovir disoproxil Zentiva is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents aged 12 years and above with liver damage whose liver is still able to work (compensated liver disease). In adults, it can also be used for those patients with liver damage whose liver does not work properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil. It is a 'generic medicine'. This means that Tenofovir disoproxil Zentiva is similar to a 'reference medicine' alreadyauthorised in the European Union (EU) called Viread. For more information on generic medicines, see the question-and-answer document here.

How is Tenofovir disoproxil Zentiva used?

Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B.Tenofovir disoproxil Zentiva is available as tablets (245 mg) to be taken by mouth. It is taken once a day with food. The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function. For more information on how the medicine is taken including doses for adults and adolescents, see the summary of product characteristics (also part of the EPAR).

How does Tenofovir disoproxil Zentiva work?

The active substance in Tenofovir disoproxil Zentiva, tenofovir disoproxil, is a 'prodrug' that is converted into tenofovir in the body.Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI). In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Tenofovir disoproxil Zentiva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called 'DNA polymerase', which is involved in the formation of viral DNA. Tenofovir disoproxil Zentiva stops the virus making DNA and prevents it from multiplying and spreading.

How has Tenofovir disoproxil Zentiva been studied?

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

What are the benefits and risks of Tenofovir disoproxil Zentiva?

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

Why is Tenofovir disoproxil Zentiva approved?

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

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

The company that markets Tenofovir disoproxil Zentiva will ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Zentiva have also been included in the summary of product characteristics and the package leaflet.


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Tepadina


What is Tepadina?

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

What is Tepadina used for?

Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways:• as a 'conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells). This type of transplant is used in patients who need to replace their blood-making cells because they have a blood disease such as a cancer of the blood (including leukaemia) or diseases causing low red blood cell counts (including thalassaemia or sickle-cell anaemia);• during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.Tepadina can be used for transplantation of cells from a donor and for transplantation of cells derived from the patient's own body.Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an 'orphan medicine' (a medicine used in rare diseases) on 29 January 2007.The medicine can only be obtained with a prescription.

How is Tepadina used?

Tepadina treatment must be supervised by a doctor who has experience in treatments given before transplantation. It must be given as an infusion into a large vein lasting two to four hours.The dose of Tepadina depends on the type of blood disease or solid tumour that the patient has and the type of transplantation to be carried out. The dose also depends on the patient's body surface area (calculated using the height and weight of the patient) or on the patient's weight. In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation. In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation. For further information, see the summary of product characteristics (also part of the EPAR).

How does Tepadina work?

The active substance in Tepadina, thiotepa, belongs to a group of medicines called 'alkylating agents'. These substances are 'cytotoxic'. This means that they kill cells, especially cells that multiply rapidly, such as cancer or progenitor (or 'stem') cells (cells that can develop into different types of cell). Tepadina is used with other medicines before transplantation to destroy the abnormal cells and the patient's existing blood-making cells. This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection.Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.

How has Tepadina been studied?

Because thiotepa has been used for many years in the EU, the company presented data from the published literature. This included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumours, who were having a transplant of blood-making cells. The studies looked at the number of patients with successful transplantations, how long it took for the diseases to come back and how long the patients survived.

What benefit has Tepadina shown during the studies?

The published studies showed that thiotepa used in combination with other chemotherapy medicines is beneficial to adults and children being treated for blood diseases and solid tumours. It helps to destroy the patient's existing blood-making cells, resulting in the successful transplantation of new cells, improved survival and a reduced risk of the diseases coming back.

What is the risk associated with Tepadina?

The most common side effects seen with Tepadina when used with other medicines are infections, cytopenia (low number of cells in the blood), graft-versus-host disease (when the transplanted cells attack the body), disorders of the gut, haemorrhagic cystitis (bleeding and inflammation in the bladder) and mucosal inflammation (inflammation of the moist body surfaces). For the full list of all side effects reported with Tepadina in adults and children, see the package leaflet.Tepadina must not be used in women who are pregnant or breast-feeding. It must also not be used together with the vaccine against yellow fever or vaccines containing live viruses or bacteria. For the full list of restrictions, see the package leaflet.

Why has Tepadina been approved?

The CHMP noted that the active substance in Tepadina, thiotepa, has a well established used. This means that it has been used for many years and that there was sufficient information on its effectiveness and safety. The Committee decided that, based on available published information, Tepadina'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 Tepadina?

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


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Tepkinly


What is Tepkinly and what is it used for?

Tepkinly is a cancer medicine used to treat adults with a blood cancer called diffuse large B-cell lymphoma (DLBCL) whose cancer has returned (relapsed) or stopped responding (refractory) after at least two previous treatments.DLBCL is rare, and Tepkinly was designated an 'orphan medicine' (a medicine used in rare diseases) on 24 February 2022. Further information on the orphan designation can be found on the EMA website.Tepkinly contains the active substance epcoritamab.

How is Tepkinly used?

Tepkinly can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating cancer, in a location with appropriate medical support to manage severe side effects such as cytokine release syndrome (CRS, a potentially life-threatening condition that causes fever, vomiting, shortness of breath, headache and low blood pressure).Tepkinly is given as an injection under the skin, in cycles of 28 days. Treatment starts with injections on days 1, 8 and 15 at increasing doses (so-called step-up dosing). After step-up dosing, patients are given the full dose on certain days of each cycle. Treatment can continue until the disease gets worse or the patient experiences unacceptable side effects.Several medicines are given before Tepkinly to reduce the risk of CRS. Patients should also be closely monitored for serious side effects like CRS and immune effector cell-associated neurotoxicity syndrome (ICANS, a neurological disorder with symptoms including problems with speech and writing, confusion and depressed level of consciousness), especially after receiving the full dose for the first time.For more information about using Tepkinly, see the package leaflet or contact your doctor or pharmacist.

How does Tepkinly work?

DLBCL is a cancer that affects B cells, a type of white blood cell. The active substance in Tepkinly, epcoritamab, is an antibody (a type of protein) that recognises and attaches to two targets simultaneously: CD20, a protein that is present on the surface of B cells (including the cancer cells),and CD3, a protein found on the surface of healthy T cells (cells in the immune system). By attaching to CD20 and CD3 proteins, Tepkinly brings the cancer cells and T cells together. This encourages the T cells to destroy the cancer cells and helps control the disease.

What benefits of Tepkinly have been shown in studies?

The benefits of Tepkinly were evaluated in a study involving 157 adults with DLBCL or a related lymphoma whose cancer had returned or was not responding after at least two other treatments. In this study, Tepkinly was given for an average of four months and was not compared with other medicines or placebo (dummy treatment). Of the patients with DLBCL, 62% (86 out of 139) had either a complete response (no sign of cancer) or a partial response to Tepkinly; they maintained these responses for an average of around 16 months.

What are the risks associated with Tepkinly?

For the full list of side effects and restrictions with Tepkinly, see the package leaflet.The most common side effects with Tepkinly (which may affect more than 1 in 5 people) include CRS, tiredness, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), injection site reactions, pain in muscles and bones, abdominal (belly) pain, fever, nausea (feeling sick) and diarrhoea.The most common serious side effects (which may affect more than 3 in 10 people) was CRS.

Why is Tepkinly authorised in the EU?

Patients with DLBCL whose cancer has returned or not responded after at least two previous treatments have limited treatment options. Treatment with Tepkinly was shown to provide a clinically meaningful and durable response. Although serious side effects, particularly CRS and ICANS, can occur, they were considered manageable with appropriate measures. The European Medicines Agency therefore decided that Tepkinly's benefits are greater than its risks and it can be authorised for use in the EU.Tepkinly has been given 'conditional authorisation'. This means that the European Medicines Agency decided that the benefits of Tepkinly are greater than its risks, but the company will have to provide additional evidence after authorisation.Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available until data become comprehensive, and this overview will be updated as necessary.Since Tepkinly was given conditional authorisation, at the time of authorisation the company marketing Tepkinly was required to provide updated results from the main study. The company was also required to provide results from a study comparing Tepkinly with another immunochemotherapy in patients with relapsed or refractory DLBCL.

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

The company that markets Tepkinly will provide patients with an alert card to inform them about the risks of the serious side effects CRS and ICANS and to give instructions on when to contact their doctor if they experience symptoms. The company will also provide the final results of a study with Tepkinly to confirm the safety and benefit of the recommended dose.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tepkinly have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tepkinly are continuously monitored. Suspected side effects reported with Tepkinly are carefully evaluated and any necessary action taken to protect patients.


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Tepmetko


What is Tepmetko and what is it used for?

Tepmetko is a cancer medicine that is used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced and its cells have particular genetic mutations (changes) leading to 'mesenchymal-epithelial transition factor gene exon 14' (METex14) skipping. This means that the cancer cells make an abnormal form of a protein called MET because a part of the MET gene known as exon 14 is not used.Tepmetko is used when the patient needs further treatment after receiving immunotherapy or platinum-based chemotherapy, or both.Tepmetko contains the active substance tepotinib.

How is Tepmetko used?

The medicine can only be obtained with a prescription, and treatment should be started and supervised by a doctor who is experienced in using cancer medicines.The patient's cancer should be tested before starting treatment to confirm METex14 skipping mutations.Tepmetko is available as tablets and is taken by mouth. The recommended dose is 450 mg once per day. Treatment can continue until the patient no longer benefits from it. If certain side effects develop, the doctor may decide to reduce the dose to 225 mg once per day, or to interrupt or stop treatment with Tepmetko.For more information about using Tepmetko, see the package leaflet or contact your doctor or pharmacist.

How does Tepmetko work?

The MET protein belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells. In NSCLC patients with 'METex14 skipping', an abnormal form of the MET protein is produced that causes cancer cells to divide and grow in an uncontrolled fashion. The active substance in Tepmetko, tepotinib, is a receptor tyrosine kinase inhibitor that attaches to this abnormal METprotein inside cancer cells. This stops the effect of MET, helping to slow down the growth and spread of the cancer.

What benefits of Tepmetko have been shown in studies?

In one main study involving 138 patients, Tepmetko was effective in treating adults with NSCLC with METex14 skipping mutations whose disease had progressed after previously being treated with other cancer medicines. Tepmetko was not compared with any other treatment or placebo (dummy treatment).Response to treatment (shrinkage in the size of the cancer) was assessed using body scans. Around 44% (61 out of 138) of the patients showed partial or complete cancer shrinkage after treatment with Tepmetko. On average, responses lasted for over 11 months.

What are the risks associated with Tepmetko?

The most common side effects with Tepmetko (which may affect more than 1 in 5 people) are oedema (build-up of fluid), nausea (feeling sick), low albumin level in the blood, diarrhoea, and increase in creatinine level in the blood (a sign of kidney problems). The most common serious side effects with Tepmetko (which may affect more than 1 in 100 people) are peripheral oedema (swelling especially of the ankles and feet), generalised oedema (build-up of fluid in the whole body) and interstitial lung disease (disorder causing scarring in the lungs).For the full list of side effects and restrictions of Tepmetko, see the package leaflet.

Why is Tepmetko authorised in the EU?

There are currently no specific treatment options for patients with advanced NSCLC with METex14 skipping mutations. Although the main study did not compare Tepmetko with another cancer treatment, it showed that the medicine was effective in patients whose cancer had progressed after several different treatments. In general, Tepmetko's side effects were considered manageable.The European Medicines Agency therefore decided that Tepmetko'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 Tepmetko?

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


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Teriflunomide Accord


What is Teriflunomide Accord and what is it used for?

Teriflunomide Accord is a medicine used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation attacks the protective covering (sheath) around nerves and damages the nerves themselves.Teriflunomide Accord is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Teriflunomide Accord is a 'generic medicine'. This means that Teriflunomide Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Aubagio. For more information on generic medicines, see the question-and-answer document here.Teriflunomide Accord contains the active substance teriflunomide.

How is Teriflunomide Accord used?

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

How does Teriflunomide Accord work?

In multiple sclerosis, the immune system (the body's natural defences) incorrectly attacks the protective sheath around the nerves and the nerves themselves in the brain and spinal cord. The active substance in Teriflunomide Accord, teriflunomide, blocks an enzyme called 'dihydroorotate dehydrogenase' which is necessary for cells to multiply. The exact way teriflunomide works in MS is not known but it is thought to reduce the number of T-lymphocytes which form part of the immune system and are involved in the inflammation process. With fewer T-lymphocytes, there is less inflammation, helping to control the symptoms of MS.Send

How has Teriflunomide Accord 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, Aubagio, and do not need to be repeated for Teriflunomide Accord.As for every medicine, the company provided studies on the quality of Teriflunomide Accord. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Teriflunomide Accord?

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

Why is Teriflunomide Accord authorised in the EU?

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

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

The company that markets Teriflunomide Accord must ensure that all healthcare professionals who are expected to prescribe this medicine receive educational material containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment. The company must also provide patient education cards with key safety information for patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Teriflunomide Accord have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Teriflunomide Accord are continuously monitored. Suspected side effects reported with Teriflunomide Accord are carefully evaluated and any necessary action taken to protect patients.


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Teriflunomide Mylan


What is Teriflunomide Mylan and what is it used for?

Teriflunomide Mylan is a medicine used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation attacks the protective covering (sheath) around nerves and damages the nerves themselves.Teriflunomide Mylan is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Teriflunomide Mylan is a 'generic medicine'. This means that Teriflunomide Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Aubagio. For more information on generic medicines, see the question-and-answer document here.Teriflunomide Mylan contains the active substance teriflunomide.

How is Teriflunomide Mylan used?

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

How does Teriflunomide Mylan work?

In multiple sclerosis, the immune system (the body's natural defences) incorrectly attacks the protective sheath around the nerves and the nerves themselves in the brain and spinal cord. The active substance in Teriflunomide Mylan, teriflunomide, blocks an enzyme called 'dihydroorotate dehydrogenase' which is necessary for cells to multiply. The exact way teriflunomide works in MS is not known but it is thought to reduce the number of T-lymphocytes which form part of the immune system and are involved in the inflammation process. With fewer T-lymphocytes, there is less inflammation, helping to control the symptoms of MS.Send

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

Because Teriflunomide 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 Teriflunomide Mylan authorised in the EU?

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

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

The company that markets Teriflunomide Mylan must ensure that all healthcare professionals who are expected to prescribe this medicine receive educational material containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment. The company must also provide patient education cards with key safety information for patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Teriflunomide Mylan have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Teriflunomide Mylan are continuously monitored. Suspected side effects reported with Teriflunomide Mylan are carefully evaluated and any necessary action taken to protect patients.


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Teriparatide Sun


What is Teriparatide Sun and what is it used for?

Teriparatide Sun is a medicine used to treat adults with osteoporosis (a disease that makes the bones fragile) in women who have been through menopause and in men who are at an increased risk of fractures. The medicine is also used to treat osteoporosis in men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).Teriparatide Sun is a 'hybrid medicine', meaning that it is similar to a 'reference medicine' containing the same active substance, but there are certain differences between the two. The reference medicine for Teriparatide Sun is Forsteo, in which the active substance is of biological origin (produced using bacteria), whereas in Teriparatide Sun it is chemically synthesised.Teriparatide Sun contains the active substance teriparatide.

How is Teriparatide Sun used?

Teriparatide Sun can only be obtained with a prescription. The medicine is available as a pre-filled pen and patients may inject themselves once they have been trained to do so. The recommended dose is 20 micrograms given once a day as an injection under the skin of the thigh or abdomen (tummy).The medicine can be used for up to two years. Only one two-year course of Teriparatide Sun should be given to a patient in their lifetime.Patients should receive calcium and vitamin D supplements if they cannot get the recommended amounts from their diet.For more information about using Teriparatide Sun, see the package leaflet or contact your doctor or pharmacist.

How does Teriparatide Sun work?

Bones are made of a tissue that is constantly being broken down and replaced. Osteoporosis happens when the amount of new bone forming is not enough to replace the bone that is broken down. In people with osteoporosis, bones become thin and fragile and are more likely to break.In women, osteoporosis is more common after menopause, when levels of the hormone oestrogen fall. Osteoporosis can also occur in both sexes as a side effect of prolonged treatment with glucocorticoid medications and due to other risk factors, such as age, smoking or use of medicines that cause bone loss or high bone turnover.The active substance in Teriparatide Sun, teriparatide, is identical to part of the human parathyroid hormone. It acts like this hormone to increase bone formation by stimulating osteoblasts(bone-forming cells), to increase the absorption of calcium from food and to help prevent too much calcium being lost in the urine.

What benefits of Teriparatide Sun have been shown in studies?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Forsteo, and do not all need to be repeated for Teriparatide Sun. As for every medicine, the company provided studies on the quality of Teriparatide Sun. Because the active substance in Forsteo is produced differently compared with Teriparatide Sun, the company also presented results from laboratory studies showing bioequivalence to the reference medicine, meaning that they both produce the same levels of active substance in the body, and are therefore expected to have the same effect.

What are the risks associated with Teriparatide Sun?

The most common side effects with Teriparatide Sun (which may affect more than 1 in 10 people) are nausea (feeling sick), pain in the arms and legs, headache and dizziness. For the full list of side effects of Teriparatide Sun, see the package leaflet.Teriparatide Sun must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease. Teriparatide Sun must also not be used during pregnancy or breastfeeding.For the full list of restrictions, see the package leaflet.

Why is Teriparatide Sun authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Teriparatide Sun was of comparable quality and was bioequivalent to the reference medicine Forsteo. Therefore, the Agency decided that the benefits of Teriparatide Sun 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 Teriparatide Sun?

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


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Terrosa


What is Terrosa and what is it used for?

Terrosa is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:• women who have been through the menopause. In these patients, Terrosa has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;• men who are at an increased risk of fractures;• men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).Terrosa contains the active substance teriparatide.Terrosa is a 'biosimilar medicine'. This means that Terrosa is highly similar to a biological medicine (also known as the 'reference medicine') that is already authorised in the European Union (EU). The reference medicine for Terrosa is Forsteo. For more information on biosimilar medicines, see the question-and-answer document here.

How is Terrosa used?

Terrosa is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended to be used with ServoPen Fix system. The recommended dose is 20 micrograms of Terrosa given once a day as an injection under the skin of the thigh or abdomen (belly). Patients may inject themselves once they have been trained.Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Terrosa can be used for up to two years. The two-year course of Terrosa should be given only once during a patient's lifetime.The medicine can only be obtained with a prescription.

How does Terrosa work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become less dense and more likely to break. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall. Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.The active substance in Terrosa, teriparatide, is identical to part of the human parathyroid hormone. It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells). It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.

What benefits of Terrosa have been shown in studies?

Laboratory studies comparing Terrosa with Forsteo have shown that the active substance in Terrosa is highly similar to that in Forsteo in terms of structure, purity and biological activity.Because Terrosa is a biosimilar medicine, the studies on effectiveness and safety of teriparatide carried out with Forsteo do not need to be repeated for Terrosa. A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body. Further, Terrosa and Forsteo produced similar effects on calcium levels in the blood.

What are the risks associated with Terrosa?

The most common side effect with Terrosa (seen in more than 1 patient in 10) is pain in the arms or legs. For the full list of all side effects reported with Terrosa, see the package leaflet.Terrosa must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease. Terrosa must not be used during pregnancy or breastfeeding. For the full list of restrictions, see the package leaflet.

Why is Terrosa approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Terrosa has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way. This was considered sufficient to conclude that Terrosa will behave in thesame way in terms of effectiveness and safety. Thus, as for Forsteo, the benefit outweighs the identified risks and the Committee recommended that Terrosa be given marketing authorisation.

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

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


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Tesavel


What is Tesavel?

Tesavel is a medicine that contains the active substance sitagliptin. It is available as tablets (25, 50 and 100 mg).

What is Tesavel used for?

Tesavel is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels. It is used in addition to diet and exercise in the following ways:• on its own, in patients who are not satisfactorily controlled on diet and exercise and in whom metformin (an antidiabetes medicine) is not suitable;• in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPAR-gamma agonist used on its own;• in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable;• in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;The medicine can only be obtained with a prescription.

How is Tesavel used?

Tesavel is taken at a dose of 100 mg once a day. If Tesavel is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).In patients with moderately or severely reduced kidney function the dose of Tesavel should be reduced.

How does Tesavel 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 Tesavel, sitagliptin, 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 increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when the blood glucose is low. Sitagliptin 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.

How has Tesavel been studied?

Tesavel was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:• four of the studies compared Tesavel with placebo (a dummy treatment). Tesavel or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;• two studies compared Tesavel with other antidiabetes medicines. One study compared Tesavel with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients. The other study compared Tesavel with metformin, used on their own, in 1,058 patients;• three additional studies compared Tesavel with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.In all of the studies, the main measure of effectiveness was the change 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.

What benefit has Tesavel shown during the studies?

Tesavel was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Tesavel on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks. In contrast, they rose by0.12% and 0.18%, respectively, in the patients taking placebo. Adding Tesavel to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. When added to pioglitazone, Tesavel reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.In the studies comparing Tesavel with other medicines, the effectiveness of adding Tesavel to metformin was similar to that of adding glipizide. When taken on their own, Tesavel and metformin produced similar reductions in HbA1c levels, but the effectiveness of Tesavel seemed to be slightly lower than that of metformin.In the additional studies, adding Tesavel to glimepiride (with and without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo. HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Tesavel to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. Finally, they were reduced by 0.59% in patients adding Tesavel to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.

What is the risk associated with Tesavel?

Serious side effects reported with Tesavel include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions). Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients. For the full list of all side effects reported with Tesavel, see the package leaflet.Tesavel must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.

Why has Tesavel been approved?

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


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Tevagrastim


What is Tevagrastim?

Tevagrastim is a solution for injection or for infusion (drip into a vein). It contains the active substance filgrastim.Tevagrastim is a 'biosimilar' medicine. This means that Tevagrastim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the 'reference medicine'). The reference medicine for Tevagrastim is Neupogen. For more information on biosimilar medicines, see the question-and-answer document here.

What is Tevagrastim used for?

Tevagrastim is used to stimulate the production of white blood cells in the following situations:• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);• 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 a risk of long-term, severe neutropenia;• 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. Tevagrastim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow. The medicine can only be obtained with a prescription.

How is Tevagrastim used?

Tevagrastim is given by injection under the skin or infusion into a vein. How it is given, the dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment. Tevagrastim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. For more information, see the Package Leaflet.

How does Tevagrastim work?

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

How has Tevagrastim been studied?

Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen. Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer. The study looked at the duration of severe neutropenia during the patients' first cycle of cytotoxic chemotherapy.To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.

What benefit has Tevagrastim shown during the studies?

Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe neutropenia. During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo. Therefore, the effectiveness of Tevagrastim was shown to be equivalent to that of Neupogen.

What is the risk associated with Tevagrastim?

The most common side effect with Tevagrastim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Tevagrastim is being used for. For the full list of all side effects reported with Tevagrastim, see the Package Leaflet.Tevagrastim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.

Why has Tevagrastim been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk. The Committee recommended that Tevagrastim be given marketing authorisation.


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Tevimbra


What is Tevimbra and what is it used for?

Tevimbra is a cancer medicine used to treat adults with squamous oesophageal cancer (cancer of the oesophagus, the passage from the mouth to the stomach) if the cancer is advanced, has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). It is used after cancer treatment with platinum-based medicines has not worked well enough.Oesophageal cancer is rare, and Tevimbra was designated an 'orphan medicine' (a medicine used in rare diseases) on 13 November 2020. Further information on the orphan designation can be found on the EMA website.Tevimbra contains the active substance tislelizumab.

How is Tevimbra used?

Treatment with Tevimbra must be started and supervised by a doctor experienced in treating cancer.The medicine can only be obtained with a prescription.Tevimbra is given as an infusion (drip) into a vein every three weeks, and treatment can continue until the disease gets worse. The doctor may delay doses if certain side effects occur or stop treatment altogether if side effects are severe.For more information about using Tevimbra, see the package leaflet or contact your doctor or pharmacist.

How does Tevimbra work?

The active substance in Tevimbra, tislelizumab, is a monoclonal antibody, a protein that has been designed to block a receptor (target) called PD-1 on certain cells of the immune system (the body's natural defences). Some cancers can make proteins (PD-L1 and PD-L2) that combine with PD-1 to switch off the activity of the immune cells, preventing them from attacking the cancer. By blocking PD-1, tislelizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.

What benefits of Tevimbra have been shown in studies?

A main study involved 512 adults with advanced or metastatic squamous oesophageal cancer whose disease had worsened after treatment with platinum-based chemotherapy. Patients treated with Tevimbra lived on average for 8.6 months compared with patients treated with other cancer medicines (paclitaxel, docetaxel or irinotecan), who lived on average for 6.3 months.

What are the risks associated with Tevimbra?

For the full list of side effects and restrictions with Tevimbra, see the package leaflet.The most common side effect with Tevimbra (which may affect more than 1 in 5 people) was anaemia (low red blood cell counts). Other common side effects (which may affect more than 1 in 10 people) include hypothyroidism (an underactive thyroid gland), cough, rash, itching, tiredness and decreased appetite.The most common serious side effects (which may affect up to 1 in 10 people) include anaemia and pneumonia (infection of the lungs).

Why is Tevimbra authorised in the EU?

Tevimbra was effective at improving survival (how long patients lived) in patients with advanced or metastatic squamous oesophageal cancer who had previously received platinum-based chemotherapy. The side effects of this medicine were considered manageable and comparable to those of similar cancer medicines. The European Medicines Agency therefore decided that Tevimbra'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 Tevimbra?

The company that markets Tevimbra will provide patients with an alert card to inform them about the risks of potential immune-related side effects and give instructions on when to contact their doctor if they experience symptoms.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tevimbra have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tevimbra are continuously monitored. Suspected side effects reported with Tevimbra are carefully evaluated and any necessary action is taken to protect patients.


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Teysuno


What is Teysuno and what is it used for?

Teysuno is a cancer medicine. It belongs to a group of cancer medicines called fluoropyrimidines and is used to treat advanced gastric (stomach) cancer together with cisplatin (another cancer medicine). It is also used to treat metastatic colorectal cancer (cancer of the colon and rectum that has spread elsewhere in the body) in patients who can no longer be treated with other fluoropyrimidines because of unacceptable side effects. For this it may be used alone or with the cancer medicines oxaliplatin or irinotecan, with or without another medicine, bevacizumab.Teysuno contains the active substances tegafur, gimeracil and oteracil.

How is Teysuno used?

Teysuno should only be prescribed by a doctor who is experienced in the use of cancer medicines.Before starting treatment, it is recommended that patients are tested to check whether they have a working dihydropyrimidine dehydrogenase (DPD) enzyme.Teysuno is available as capsules containing 15 mg tegafur with 4.35 mg gimeracil and 11.8 mg oteracil, and as capsules containing 20 mg tegafur with 5.8 mg gimeracil and 15.8 mg oteracil. The recommended initial dose depends on the patient's height and weight. Teysuno capsules should be taken at least one hour before or after a meal.For the treatment of advanced gastric cancer, Teysuno is used in a four-week cycle starting on the day of cisplatin administration. The capsules are given twice daily for 21 days followed by a 7-day gap before the next course. Cisplatin treatment stops after six cycles, but Teysuno treatment is continued unless the disease gets worse or the side effects are unacceptable.For the treatment of metastatic colorectal cancer, Teysuno is used in a three-week cycle, with capsules given twice daily for 14 days, followed by a 7-day gap before starting the next cycle. Bevacizumab can be given on day 1 of each cycle. If Teysuno is given in combination with oxaliplatin and irinotecan, a lower dose is recommended.Doses need to be adjusted for patients with kidney disease and for patients who develop certain side effects. For patients with partial DPD deficiency, a lower starting dose may be considered.For more information about using Teysuno, see the package leaflet or contact your doctor or pharmacist.

How does Teysuno work?

The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills rapidly dividing cells, such as cancer cells). Tegafur is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.Fluorouracil is very similar to pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it prevents the growth of tumour cells and eventually kills them.The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of fluorouracil and oteracil by reducing the activity of fluorouracil in normal, non-cancerous tissue in the gut.

What benefits of Teysuno have been shown in studies?

Gastric cancerTeysuno has been shown to be as effective as fluorouracil in the treatment of advanced gastric cancer in clinical trials. In a main study, Teysuno was compared with the cancer medicine fluorouracil given as an infusion in 1,053 adults with advanced gastric cancer. Both medicines were given with cisplatin. The main measure of effectiveness was how long the patients lived.Treatment with Teysuno capsules was as effective as treatment with fluorouracil infusions. Patients receiving Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients receiving fluorouracil with cisplatin.Colorectal cancerThe company presented results from retrospective cohort studies in which Teysuno was used to treat metastatic colorectal cancer, after patients had experienced unacceptable side effects with other fluoropyrimidine-based treatments. In addition, the company provided a review and analysis of studies from the scientific literature in which Teysuno treatment was compared to other fluoropyrimidines for the treatment of metastatic colorectal cancer. In total, 1,062 patients treated with Teysuno-based therapies and 1,055 patients who were treated with other fluoropyrimidine-based treatments were included in this analysis. The analysis showed that both the time patients lived without their disease worsening and the time patients lived overall were comparable between patients treated with Teysuno and patients treated with other medication.

What are the risks associated with Teysuno?

In patients with advanced gastric cancer treated with Teysuno in combination with cisplatin, the most common severe side effects (which may affect more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts) and fatigue (tiredness).In patients with metastatic colorectal cancer, side effects appear similar to those seen in patients treated for advanced gastric cancer.Teysuno must not be used in the following groups:• patients currently receiving another fluoropyrimidine (a group of anticancer medicines that includes Teysuno) or who have had severe and unexpected reactions to fluoropyrimidine therapy;• patients known to have no DPD enzyme activity, as well as patients who, within the previous four weeks, have been treated with a medicine that blocks this enzyme;• pregnant or breastfeeding women;• patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);• patients with severe kidney problems requiring dialysis;• patients who should not be receiving cisplatin, oxaliplatin, irinotecan or bevacizumab.For the full list of all side effects and restrictions of Teysuno, see the package leaflet.

Why is Teysuno authorised in the EU?

Teysuno, in combination with cisplatin, has been shown to be effective in treating gastric cancer, and analysis of the literature has shown Teysuno-based treatments to be effective for metastatic colorectal cancer in patients for whom other fluoropyrimidine-based regimens are not an option because of side effects. The safety profile of the medicine is considered acceptable. The European Medicines Agency therefore decided that Teysuno'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 Teysuno?

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


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Tezspire


What is Tezspire and what is it used for?

Tezspire is a medicine used to treat adults and adolescents (12 years of age and older) with severe asthma. It is used as an additional treatment in adults and adolescents with severe asthma that is not adequately controlled by a combination of high-dose corticosteroids taken by inhalation plus another asthma medicine.Tezspire contains the active substance tezepelumab.

How is Tezspire used?

Tezspire can only be obtained with a prescription and treatment should be initiated by a doctor with experience in diagnosing and treating severe asthma.Tezspire is injected under the skin every 4 weeks. This medicine is used for long-term treatment. Every year the doctor will decide whether to continue treatment, based on the patient's level of asthma control.The patient or their caregiver may inject the medicine themselves after they have received training.Tezspire should not be used to treat asthma attacks. Patients should contact their doctor if their asthma remains uncontrolled or worsens after starting this medicine.For more information about using Tezspire, see the package leaflet or contact your doctor or pharmacist.

How does Tezspire work?

In patients with asthma, a protein called thymic stromal lymphopoietin (TSLP) plays a role in the immune response that causes inflammation in the airway. The active substance of Tezspire, tezepelumab, is an antibody (a type of protein) that prevents TSLP from attaching to its receptor and thereby reduces airway inflammation and asthma symptoms.

What benefits of Tezspire have been shown in studies?

Two main studies including over 1,500 adults and adolescents with inadequately controlled asthma showed that Tezspire was effective in reducing the number of severe asthma flare-ups.In the first study, patients given Tezspire had on average 0.93 asthma flare-ups per year after one year of treatment compared with 2.10 in patients given placebo (a dummy treatment). In the second study, patients taking Tezspire had an average of 0.20 flare-ups per year after one year, compared with 0.72 in patients who received placebo.

What are the risks associated with Tezspire?

The most common side effects with Tezspire (which may affect up to 1 in 10 people) are arthralgia (joint pain) and pharyngitis (sore throat).For the full list of side effects and restrictions of Tezspire, see the package leaflet.

Why is Tezspire authorised in the EU?

The European Medicines Agency decided that Tezspire's benefits are greater than its risks and it can be authorised for use in the EU.The Agency considered that Tezspire was effective at reducing severe asthma flare-ups. Regarding safety, side effects related to Tezspire were considered manageable.

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

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


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Thalidomide Bms


What is Thalidomide BMS and what is it used for?

Thalidomide BMS is used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before. It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.Thalidomide BMS must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.It contains the active substance thalidomide.

How is Thalidomide BMS used?

Thalidomide BMS can only be obtained with a prescription and treatment must be started and monitored under the supervision of a doctor skilled in using medicines that modulate the immune system or medicines to treat cancer. The doctor must also understand the risks of thalidomide and how its use must be monitored.Thalidomide BMS is available as capsules (50 mg). The recommended dose is 200 mg (4 capsules) a day, taken at the same time, preferably at bedtime. In patients over 75 years of age a starting dose of 100 mg (2 capsules) a day is recommended. Thalidomide BMS can be used for a maximum of 12 treatment cycles, with each cycle lasting 6 weeks. The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.For more information about using Thalidomide BMS, see the package leaflet or contact your doctor or pharmacist.

How does Thalidomide BMS work?

The active substance in Thalidomide BMS, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system (the body's1 Initially known as Thalidomide Pharmion and subsequently as Thalidomide Celgene.natural defences) to attack the cancer cells. This can help to slow down the progression of multiple myeloma.

What benefits of Thalidomide BMS have been shown in studies?

Thalidomide BMS increased the time patients lived in one main study involving 447 patients with multiple myeloma. The study included patients over 65 years of age, as well as younger patients who could not be treated with high-dose chemotherapy. The study compared the effect of melphalan and prednisone, with or without Thalidomide BMS. Patients receiving melphalan and prednisone lived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide BMS.The company also presented the results of a study looking at the combination of Thalidomide BMS and dexamethasone as 'induction' treatment for multiple myeloma for use before high-dose chemotherapy.However, it withdrew this application during the initial assessment of the medicine.

What are the risks associated with Thalidomide BMS?

Most patients taking thalidomide get side effects. The most common side effects with Thalidomide BMS used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), sleepiness, constipation and peripheral oedema (swelling, usually in the legs). For the full list of side effects reported with Thalidomide BMS, see the package leaflet.Thalidomide is a powerful human 'teratogen', meaning that it has harmful effect on the unborn child, causing severe and life-threatening birth defects. The strict conditions put in place to prevent pregnancy and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.Thalidomide BMS must never be used by the following groups:• women who are pregnant;• women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;• patients who are unable to follow or to comply with the requirement to use contraceptives.For the full list of restrictions, see the package leaflet.

Why is Thalidomide BMS authorised in the EU?

Thalidomide BMS, in combination with melphalan and prednisone, has been shown to prolong the life of patients with multiple myeloma. The European Medicines Agency concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide BMS's benefits are greater than its risks and it can be authorised for use in the EU.Thalidomide BMS0F

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

The company that markets Thalidomide BMS will set up a pregnancy prevention programme in each Member State. It will provide educational kits for healthcare workers and brochures for patients, detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards for patients to ensure that all appropriate safety measures are taken by each patient. Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.The company will also collect information on whether the medicine is used outside its approved indication. The boxes containing Thalidomide BMS capsules will include a warning that thalidomide is harmful to the unborn child.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thalidomide BMS have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Thalidomide BMS are continuously monitored. Side effects reported with Thalidomide BMS are carefully evaluated and any necessary action taken to protect patients.


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Thalidomide Lipomed


What is Thalidomide Lipomed and what is it used for?

Thalidomide Lipomed is a medicine used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before. It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.It contains the active substance thalidomide.Thalidomide Lipomed is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but with certain differences. While the reference medicine, Thalidomide BMS, is a 50 mg capsule, Thalidomide Lipomed is a 100 mg tablet.

How is Thalidomide Lipomed used?

Thalidomide Lipomed must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.Treatment must be started and monitored under the supervision of a doctor skilled in using medicines that modulate the immune system or medicines to treat cancer. The doctor must also understand the risks of thalidomide and how its use must be monitored.Thalidomide Lipomed is available as tablets (100 mg). The recommended dose is 200 mg (2 tablets) a day, taken at the same time, preferably at bedtime. In patients over 75 years of age, a starting dose of 100 mg (1 tablet) a day is recommended. Thalidomide Lipomed can be used for a maximum of 12 treatment cycles, with each cycle lasting 6 weeks. The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.For more information about using Thalidomide Lipomed, see the package leaflet or contact your doctor or pharmacist.

How does Thalidomide Lipomed work?

The active substance in Thalidomide Lipomed, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating specialised cells of the immune system (the body'snatural defences) to attack the cancer cells. This can help to slow down the progression of multiple myeloma.

What benefits of Thalidomide Lipomed have been shown in studies?

The company provided information from the published literature on the benefits and risks of thalidomide in the approved uses.As for every medicine, the company provided studies on the quality of Thalidomide Lipomed. It also carried out a study to show bioequivalence with Thalidomide BMS. 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. Although the study did not find that the medicines were bioequivalent, the difference was very small and did not affect how effective Thalidomide Lipomed is or its safety profile.

What are the risks associated with Thalidomide Lipomed?

Most patients taking thalidomide get side effects. The most common side effects with Thalidomide Lipomed used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage in arms and legs, causing pain or numbness, burning and tingling), tremor (shaking), dizziness, paraesthesia (sensations like numbness, tingling, pins and needles), dysaesthesia (unpleasant and abnormal feeling when touched), sleepiness, constipation and peripheral oedema (swelling especially of the ankles and feet). For the full list of side effects reported with Thalidomide Lipomed, see the package leaflet.Thalidomide is a powerful human 'teratogen', meaning that it has harmful effect on the unborn child, causing severe and life-threatening birth defects. The strict conditions put in place to prevent pregnancy and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.Thalidomide Lipomed must never be used by the following groups:• women who are pregnant;• women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;• male patients who are unable to follow or to comply with the requirement to use contraceptives.For the full list of restrictions, see the package leaflet.

Why is Thalidomide Lipomed authorised in the EU?

The European Medicines Agency concluded that although Thalidomide Lipomed was not shown to be bioequivalent to Thalidomide BMS, the difference is small and does not lead to a change in effects or result in safety issues. Therefore the Agency decided that, as for Thalidomide BMS, the benefit of Thalidomide Lipomed outweighs its 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 Thalidomide Lipomed?

The company that markets Thalidomide Lipomed will set up a pregnancy prevention programme in each Member State. It will provide educational kits for healthcare workers and brochures for patients, detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards for patients to ensure that all appropriate safety measures are taken by each patient. Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.The company will also collect information on whether the medicine is used outside its approved indication. The boxes containing Thalidomide Lipomed tablets will include a warning that thalidomide is harmful to the unborn child.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thalidomide Lipomed have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Thalidomide Lipomed are continuously monitored. Side effects reported with Thalidomide Lipomed are carefully evaluated and any necessary action taken to protect patients.


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Thiotepa Riemser


What is Thiotepa Riemser and what is it used for?

Thiotepa Riemser is used in combination with chemotherapy in two ways:• as a 'conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells). This type of transplant is used in patients who need replacement blood-making cells because they have a blood disease such as a cancer of the blood (e.g. leukaemia) or diseases causing low red-blood cell counts (including thalassaemia or sickle-cell anaemia);• during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.Thiotepa Riemser can be used for transplantation of progenitor cells from a donor or for transplantation of progenitor cells from the patient's own body.Thiotepa Riemser contains the active substance thiotepa and is a 'generic medicine'. This means that Thiotepa Riemser contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Tepadina. For more information on generic medicines, see the question-and-answer document here.

How is Thiotepa Riemser used?

Thiotepa Riemser can only be obtained with a prescription. The medicine must be given under the supervision of a doctor who has experience in conditioning treatments given before transplantation.Thiotepa Riemser is given by infusion (drip) into a large vein over 2 to 4 hours. The dose depends on the type of blood disease or tumour that the patient has and the type of transplantation to be carried out as well as the patient's weight or weight and height.For more information about using Thiotepa Riemser, see the package leaflet or contact your doctor or pharmacist.Send

How does Thiotepa Riemser work?

The active substance in Thiotepa Riemser, thiotepa, belongs to a group of medicines called 'alkylating agents'. These substances are 'cytotoxic'. This means that they kill cells, especially cells that multiply rapidly, such as cancer of progenitor (or 'stem') cells (cells that can develop into different types of cell).Thiotepa Riemser is used with other medicines before transplantation to destroy the abnormal cells and the patient's existing blood-making cells. This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection. Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.

How has Thiotepa Riemser been studied?

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

What are the benefits and risks of Thiotepa Riemser?

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

Why is Thiotepa Riemser authorised in the EU?

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

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


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Thyrogen


What is Thyrogen?

Thyrogen is a powder that is made up into a solution for injection. It contains the active substance thyrotropin alfa.

What is Thyrogen used for?

Thyrogen is used in patients who have had thyroidectomy (thyroid surgery) because of cancer, to detect any thyroid tissue that might have been left over after the surgery.Thyrogen can also be used in combination with radioactive iodine to ablate (eliminate) any remaining thyroid tissue in patients who have had all or almost all of their thyroid gland removed and whose cancer has not spread to other parts of the body.The medicine can only be obtained with a prescription.

How is Thyrogen used?

The use of Thyrogen should be supervised by a doctor with expertise in thyroid cancer.It is given as two injections into the buttock muscle, 24 hours apart. Seventy-two hours after the last injection, a blood test is carried out to check for the presence of a thyroid protein called thyroglobulin, which indicates the presence of thyroid tissue. Another way to check for left-over tissue is to give the patient a dose of radioactive iodine that will show up in the thyroid tissue on a scan. The iodine is given 24 hours after the last Thyrogen injection and scan is performed 48 to 72 hours later.When Thyrogen is used to eliminate left-over thyroid tissue, radioactive iodine is also given 24 hours after the last Thyrogen injection. In these cases, a scan will be carried out a few days later to see if there is any more thyroid tissue left.

How does Thyrogen work?

For thyroid tissue to be detected, it needs to be active, and this requires the presence of a hormone called thyroid stimulating hormone (TSH). However, patients who have had their thyroid gland removed receive medication (thyroid hormone replacement therapy) that stops their production of TSH.The active substance in Thyrogen, thyrotropin alfa, is a copy of TSH and is used to stimulate any remaining thyroid tissue in the body, including cancerous tissue. The presence of thyroid tissue can be checked by a blood test (showing that the thyroid protein thyroglobulin is being produced by any remaining thyroid tissue) or, if the patient has been given radioactive iodine, by a scan (showing that the remaining thyroid tissue is actively taking up the iodine).Thyrogen can be used to eliminate remaining thyroid tissue when the patient is given higher doses of radioactive iodine. This is because Thyrogen will stimulate the cells in the tissue to take up the radioactive iodine, which then eliminates them.Thyrotropin alfa is produced by a method known as 'recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes the cell able to produce the hormone.

How has Thyrogen been studied?

Thyrogen was used in two studies to detect any remaining thyroid tissue in 381 patients who had had thyroidectomy (thyroid surgery). In these studies the ability of Thyrogen to stimulate left-over thyroid tissue was compared with the patients' own TSH. To do this, measurements of thyroid stimulation (production of thyroglobulin and uptake of radioactive iodine) were taken twice: once after treatment with Thyrogen and once after the patients had stopped taking the replacement therapy that inhibits their natural TSH production.The results of the two measurements were compared to see if they were in agreement. The company also presented the results of studies from the published literature looking at Thyrogen's effect when it was used with a thyroglobulin test, but without a radioactive iodine scan. The thyroglobulin test is an alternative to the radioactive iodine scan for detecting remaining thyroid tissue which involves measuring thyroglobulin produced by the thyroid tissue in the blood.Thyrogen was used to eliminate any left-over thyroid tissue in a study involving 63 patients with thyroid cancer who were given higher doses of radioactive iodine. This study also compared Thyrogen with the patients' own TSH. The main measure of effectiveness was based on a test to see if the patient had any thyroid tissue remaining at eight months after treatment. Following this, 51 of the patients went on to be followed up for an average of three and a half more years. The company also presented the results of 13 studies from the published literature, including one key study that compared the effect of Thyrogen and the effect of stopping replacement therapy in 394 patients who were followed up for around two and a half years. Two further published studies involving 1,190 patients were carried out with Thyrogen using lower doses of radioactive iodine.

What benefit has Thyrogen shown during the studies?

Using Thyrogen to detect left over thyroid tissue following surgery was comparable with using the patients' own TSH after their replacement therapy was stopped. However, Thyrogen has the advantageof allowing patients to remain on their replacement therapy before the test is carried out, resulting in a better quality of life, as the temporary withdrawal of the replacement therapy has transient sideeffects which cannot always be tolerated easily. The published studies showed that using Thyrogen was also effective in low-risk patients when leftover tissue was detected only by measuring thyroglobulin levels and that it was not always necessary to do a radioactive iodine scan.For eliminating remaining thyroid tissue following thyroid cancer surgery, both treatments were 100% successful after eight months. This finding was confirmed in the follow-up study: all 43 patients whose results could be evaluated after a further three and a half years had successful treatment. This included 25 patients using Thyrogen and 18 whose replacement therapy was stopped. The larger published studies confirmed that Thyrogen had a similar effect to stopping replacement therapy in patients whose cancer had not spread to other parts of the body. Thyrogen used with lower doses of radioactive iodine was also shown to be effective.

What is the risk associated with Thyrogen?

The most common side effect with Thyrogen (seen in more than 1 patient in 10) is nausea (feeling sick). For the full list of all side effects reported with Thyrogen, see the package leaflet.Thyrogen should not be used in people who may be hypersensitive (allergic) to bovine (cow) or human TSH or to any of the other ingredients. Thyrogen must not be used during pregnancy.

Why has Thyrogen been approved?

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


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Tibsovo


What is Tibsovo and what is it used for?

Tibsovo is a cancer medicine used to treat adults with:• acute myeloid leukaemia (AML) that is newly diagnosed. For the treatment of AML, the medicine is used in combination with azacitidine (another cancer medicine). The medicine can only be used in patients whose cancer cells have an 'IDH1 R132 mutation', a specific mutation (change) in the gene for a protein called isocitrate dehydrogenase-1 (IDH1), and who cannot be treated with standard chemotherapy;• biliary tract cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). For the treatment of biliary tract cancer, the medicine is used on its own. It can only be used in patients whose cancer has an IDH1 R132 mutation and who have received at least one prior systemic treatment (treatment given by mouth or injection).These diseases are rare, and Tibsovo 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 (acute myeloid leukaemia: 12 December 2016; biliary tract cancer: 21 March 2018).Tibsovo contains the active substance ivosidenib.

How is Tibsovo used?

Tibsovo can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in treatment of cancer.The medicine is available as tablets, to be taken by mouth.For the treatment of AML, the medicine is taken once a day in combination with azacitidine for seven days at the start of each 28-day treatment period (also known as a 'cycle'). Treatment should continue for as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.For the treatment of biliary tract cancer, the medicine is taken once a day. Treatment should continue until the disease gets worse or until treatment is no longer tolerated by the patient.For more information about using Tibsovo, see the package leaflet or contact your doctor or pharmacist.

How does Tibsovo work?

Some patients with AML or biliary tract cancer have a mutation in the gene for the IDH1 protein. This causes the protein to not work properly, resulting in the production of high levels of a substance called2-hydroxyglutarate (2-HG), which in turn contributes to cell changes which can lead to the development of cancer. The active substance in Tibsovo, ivosidenib, blocks the action of the faulty IDH1 protein, thereby lowering the production of 2-HG. This, in turn, slows down the growth and spread of the cancer.

What benefits of Tibsovo have been shown in studies?

Acute myeloid leukaemiaTibsovo was investigated in a main study involving 146 adults with previously untreated AML. All patients had mutations in the gene for IDH1. Patients were given either Tibsovo or placebo (a dummy treatment), both in combination with azacitidine, and the study looked at the percentage of patients who experienced certain outcomes (an 'event', meaning their treatment stopped working, their cancer returned or they died). The study showed that Tibsovo reduced the proportion of patients who experienced an event by 67%: 64% (46 out of 72) of the patients given Tibsovo experienced an event, compared with 84% (62 out of 74) of patients on placebo. In addition, patients given Tibsovo lived on average for 24 months after starting treatment, compared with 8 months for patients given placebo.Biliary tract cancerTibsovo was investigated in a main study involving 187 adults with biliary tract cancer that had spread or that could not be removed with surgery, and who had previously received at least one systemic treatment. All patients had the IDH1 R132 mutation.Patients given Tibsovo lived on average for 2.7 months without their disease getting worse and 10.3 months overall, compared with 1.4 months and 7.5 months, respectively, for patients given placebo. In the study, 52% (64 out of 124) of patients given Tibsovo experienced worsening of their disease and 10% (12 patients) died, compared with 72% (44 out of 61) and 10% (6 patients) of those on placebo.

What are the risks associated with Tibsovo?

For the full list of side effects and restrictions with Tibsovo, see the package leaflet.The most common side effects with Tibsovo (which may affect more than 1 in 10 people) when given in combination with azacitidine to treat AML include vomiting, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), thrombocytopenia (low levels of blood platelets), QT prolongation (abnormal activity of the heart that affects its rhythm) and insomnia (difficulty falling and staying asleep, and poor quality of sleep). The most common serious side effects (which may affect up to 1 in 10 people) include differentiation syndrome (a potentially life-threatening complication of certain treatments used for AML) and thrombocytopenia.When given alone to treat biliary tract cancer, the most common side effects with Tibsovo (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), abdominal pain, diarrhoea, decreased appetite, ascites (fluid build-up in the belly), vomiting, anaemia (low levels of red blood cells) and rash. The most common serious side effects (which may affect up to 1 in 10 people) include ascites, hyperbilirubinaemia (high blood levels of bilirubin, indicating liver problems), and cholestatic jaundice (yellowing of the skin and eyes due to blockage of bile ducts).Tibsovo must not be given with medicines called 'strong CYP3A4 inducers' as these may affect the levels of Tibsovo in the blood. In addition, it must not be given together with dabigatran (an 'anticoagulant' or blood thinning medicine) or to patients with certain heart rhythm problems.

Why is Tibsovo authorised in the EU?

For patients with AML, treatment with Tibsovo prolonged the time they lived before an event occurred(treatment no longer working, the return of the cancer or death), as well as the time they lived overall. In patients with biliary tract cancer, Tibsovo reduced the risk of disease progression. Both AML and biliary tract cancer patients have a generally poor prognosis. Side effects of the medicine are considered manageable. Known risks of heart rhythm problems are managed by restricting the use of the medicine in patients at high risk for these events, and risks of differentiation syndrome are mitigated by provision of educational materials to patients with AML. The European Medicines Agency therefore decided that Tibsovo'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 Tibsovo?

The company that markets Tibsovo will provide 'alert cards' for patients with AML to explain the risks of differentiation syndrome, its signs and symptoms and when to seek medical help.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tibsovo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tibsovo are continuously monitored. Suspected side effects reported with Tibsovo are carefully evaluated and any necessary action taken to protect patients.


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Tigecycline Accord


What is Tigecycline Accord and what is it used for?

Tigecycline Accord is a medicine used to treat adults and children older than eight years with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes. It is also used to treat complicated infections in the abdomen. 'Complicated' means that the infection is difficult to treat because it has spread, or the patient has other conditions that makes treatment difficult. Tigecycline Accord should be used only when other antibiotics are not suitable. Before using Tigecycline Accord, doctors should consider official guidance on the appropriate use of antibiotics.Tigecycline Accord is a 'generic medicine'. This means that Tigecycline Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Tygacil. For more information on generic medicines, see the question-and-answer document here.Tigecycline Accord contains the active substance tigecycline.

How is Tigecycline Accord used?

Tigecycline Accord is available as a powder that is made up into a solution for infusion (drip) into a vein. In adults, the recommended dose of Tigecycline Accord is a starting dose of 100 mg, followed by 50 mg every 12 hours for five to 14 days. Each infusion should last between 30 and 60 minutes. The length of treatment depends on where the infection is, how severe it is, and the patient's response to treatment. Doses are lower in patients with severe liver problems.In children above eight years of age, treatment is only given after consulting with a doctor with appropriate experience in the management of infectious diseases, and should be given as an infusion over a period of 60 minutes. In children from 8 to 12 years old a dose of 1.2 mg per kilogram body weight is given by infusion into a vein every 12 hours, up to a maximum dose of 50 mg every 12 hours. Treatment lasts from 5 to 14 days. In children from 12 to 18 years a dose of 50 mg is given every 12 hours for a period of 5 to 14 days.The medicine can only be obtained with a prescription.For more information about using Tigecycline Accord, see the package leaflet or contact your doctor or pharmacist.Send

How does Tigecycline Accord work?

The active substance in Tigecycline Accord, tigecycline, belongs to a group of antibiotics called 'glycylcyclines'. It works by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made. By blocking the production of new proteins, the bacteria cannot multiply and they eventually die.

How has Tigecycline Accord been studied?

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

What are the benefits and risks of Tigecycline Accord?

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

Why is Tigecycline Accord authorised in the EU?

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

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

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


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Tivicay


What is Tivicay and what is it used for?

Tivicay is a medicine used together with other medicines to treat adults and children from 4 weeks of age and weighing at least 3 kg who are infected with human immunodeficiency virus (HIV), a virus that causes acquired immune deficiency syndrome (AIDS).Tivicay contains the active substance dolutegravir.

How is Tivicay used?

Tivicay can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.Tivicay is available as tablets and dispersible tablets, which have different doses and should not be interchanged without dose adjustment. The adult dose depends on whether the infection is known or suspected to be resistant to medicines of the class to which Tivicay belongs (integrase inhibitors), and whether patients are also taking certain medicines that decrease the effectiveness of Tivicay.The dose for children depends on the age and weight of the child; children aged 6 years and above and weighing at least 14 kg are normally given tablets while dispersible tablets must be used in younger children.Although Tivicay can normally be taken with or without food, patients whose virus is resistant to this class of medicines should take Tivicay with food, as it helps the medicine to be absorbed better.For more information about using Tivicay, see the package leaflet or contact your doctor or pharmacist.

How does Tivicay work?

The active substance in Tivicay, dolutegravir, is an integrase inhibitor. This is an antiviral medicine that blocks an enzyme called integrase that the virus needs to make new copies of itself in the body. Tivicay does not cure HIV infection, but when given with other medicines it reduces the amount of virus in the body and keeps it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Tivicay have been shown in studies?

Tivicay was effective against HIV-1 in four main studies. The main measure of effectiveness in all the studies was the response rate, which was the proportion of patients with an undetectable level of the virus (below 50 copies per ml).Two studies involved patients who had not previously been treated for HIV:• In the first of these, involving 822 patients, Tivicay once daily was compared with raltegravir (another integrase inhibitor), both given in combination with two other HIV medicines of a different class (known as nucleoside reverse transcriptase inhibitors or NRTIs): 88% of those given Tivicay and 85% of those given raltegravir responded after 48 weeks of treatment.• The second study involved 833 patients given either a combination of Tivicay with two NRTIs or a different three-drug combination (Atripla) that did not include an integrase inhibitor. The response rate at 48 weeks was 88% in those given Tivicay-based treatment compared with 81% in those given Atripla.Two other studies looked at the effectiveness of Tivicay in patients whose previous HIV treatment had stopped working:• The first of these involved 724 patients whose previous treatment had not included an integrase inhibitor and whose infection was therefore not expected to be resistant to this class of medicines. Patients were treated with a combination of HIV medicines that included either Tivicay or raltegravir. Response rate at 48 weeks was 71% in patients given treatment based on Tivicay and 64% in those given treatment based on raltegravir.• The second study involved 183 patients with infection resistant to previous treatment that had involved an integrase inhibitor (i.e., their infection was resistant to several classes of medicine, including previous integrase inhibitors). Adding Tivicay twice daily to other treatment resulted in a response rate of 69% after 24 weeks of therapy.Studies were also carried out to show that recommended doses of tablets and dispersible tablets in children produced levels of the active substance in the body that are effective in controlling the virus.

What are the risks associated with Tivicay?

The most common side effects with Tivicay (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, and headache. More serious adverse effects that have been reported include an uncommon but severe hypersensitivity (allergic) reaction with rash and possible effects on the liver.For the full list of side effects of Tivicay, see the package leaflet.Tivicay must not be used together with certain medicines such as fampridine (a multiple sclerosis medicine, also called dalfampridine), as this may increase the level of such medicines in the body, resulting in serious side effects.For the full list of restrictions, see the package leaflet.

Why is Tivicay authorised in the EU?

The European Medicines Agency noted that Tivicay had demonstrated effectiveness in both untreated and previously treated patients, including those with resistance to integrase inhibitors. The medicinewas generally well tolerated, although the Agency noted the possible risk of infrequent but severe hypersensitivity reactions.The European Medicines Agency therefore decided that Tivicay'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 Tivicay?

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


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Tobi Podhaler


What is Tobi Podhaler?

Tobi Podhaler is a medicine that contains the active substance tobramycin. It is available as capsules (28 mg) containing a dry powder for inhalation using a portable inhaler device.

What is Tobi Podhaler used for?

Tobi Podhaler is used to suppress chronic lung infection caused by bacteria called Pseudomonas aeruginosa in adults and children aged 6 years and over who have cystic fibrosis. Cystic fibrosis is an inherited disease in which there is accumulation of thick mucus in the lungs that allows bacteria to grow more easily causing infections. P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.Because the number of patients with cystic fibrosis and P. aeruginosa bacterial lung infection is low, the disease is considered 'rare' and Tobi Podhaler was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 March 2003.The medicine can only be obtained with a prescription.

How is Tobi Podhaler used?

Tobi Podhaler is inhaled using a hand-held device called Podhaler. The capsules are only to be inserted into the Podhaler and must never be swallowed. The recommended dose is four capsules twice a day (as close as possible to 12 hour intervals) for four weeks, followed by four weeks without treatment.The patient should continue with a cycle of four weeks 'on' treatment followed by four weeks 'off'treatment for as long as the doctor believes the patient is benefiting from it. If the patient's lung infection gets worse, the doctor should consider replacing or adding another treatment to Tobi Podhaler. For more information on how to use Tobi Podhaler, see the instructions in the package leaflet.

How does Tobi Podhaler work?

The active substance in Tobi Podhaler, tobramycin, is an antibiotic that belongs to the group 'aminoglycosides'. It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls. This damages the bacteria and eventually kills them.Tobramycin is a well-known antibiotic that has been used to treat lung infection in cystic fibrosis patients, available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in). Tobi Podhaler is intended to increase the convenience of taking tobramycin for patients.

How has Tobi Podhaler been studied?

The applicant presented data on an existing nebuliser solution containing tobramycin called Tobi. They also presented data from the published literature.Tobi Podhaler was studied in two main trials in patients who had cystic fibrosis with P. aeruginosa lung infection. The first trial, which involved 102 patients aged 6 to 21 years, compared Tobi Podhaler with placebo (a dummy treatment), while the second, involving 553 mostly adult patients, compared it with Tobi. The trials lasted 24 weeks (three treatment cycles). The main measure of effectiveness was the change in FEV1 at the end of the treatment period of cycle 1 in the first study and at the end of the treatment period of cycle 3 in the second study. FEV1 is the most air a person can breathe out in one second.

What benefit has Tobi Podhaler shown during the studies?

Tobi Podhaler was more effective than placebo in treating P. aeruginosa infection in patients with cystic fibrosis. After four weeks of treatment, the patients taking Tobi Podhaler had an improvement in FEV1 of 13.2%, while patients taking placebo had a reduction in FEV1 of around 0.6%. When the patients in the placebo group were switched to Tobi Podhaler for the second and third cycles they also experienced a similar improvement in FEV1. The effect of Tobi Podhaler was similar to that of Tobi after three cycles of treatment.

What is the risk associated with Tobi Podhaler?

The most common side effects with Tobi Podhaler (seen in more than 1 patient in 10) are haemoptysis (coughing up blood), dyspnoea (difficulty breathing), dysphonia (hoarseness), cough and productive cough (producing mucus), oropharyngeal pain (affecting the mouth and throat) and pyrexia (fever). For the full list of all side effects reported with Tobi Podhaler, see the package leaflet.Tobi Podhaler must not be used in people who are hypersensitive (allergic) to tobramycin, any aminoglycoside or any of the other ingredients.

Why has Tobi Podhaler been approved?

The CHMP decided that Tobi Podhaler's benefits are greater than its risks, since it is effective at treating lung infection in cystic fibrosis patients and given its added convenience for patients. The Committee therefore recommended that it be given marketing authorisation.

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

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


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Tolucombi


What is Tolucombi and what is it used for?

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

How is Tolucombi used?

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

How does Tolucombi work?

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

How has Tolucombi been studied?

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

What are the benefits and risks of Tolucombi?

Because Tolucombi 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 Tolucombi approved?

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

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

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


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Tolura


What is Tolura?

Tolura is a medicine that contains the active substance telmisartan. It is available as white tablets (round: 20 mg; oval: 40 mg; capsule-shaped: 80 mg).Tolura is a 'generic medicine'. This means that Tolura is similar to a 'reference medicine' already authorised in the European Union (EU) called Micardis. For more information on generic medicines, see the question-and-answer document here.

What is Tolura used for?

Tolura is used to treat essential hypertension (high blood pressure) in adults. 'Essential' means that the hypertension has no obvious cause.Tolura is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks. It is used in patients who have had problems due to blood clots in the past (such as heart disease or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).The medicine can only be obtained with a prescription.

How is Tolura used?

For the treatment of essential hypertension, the recommended dose of Tolura is 40 mg once a day, but some patients may benefit from using a 20-mg dose. If the target blood pressure is not reached, thedose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient's blood pressure closely when starting Tolura, and may decide to adjust the patient's blood pressure-lowering medication.

How does Tolura work?

The active substance in Tolura, telmisartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack. It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.

How has Tolura been studied?

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

What are the benefit and risk of Tolura?

Because Tolura is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.

Why has Tolura been approved?

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


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Tolvaptan Accord


What is Tolvaptan Accord and what is it used for?

Tolvaptan Accord is a medicine for treating abnormally low levels of sodium in the blood in adults with a condition called 'syndrome of inappropriate antidiuretic hormone secretion' (SIADH).In people with SIADH, an excessive amount of the hormone vasopressin makes them produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.Tolvaptan Accord is a 'generic medicine'. This means that Tolvaptan Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Tolvaptan Accord is called Samsca. For more information on generic medicines, see the question-and-answer document here.Tolvaptan Accord contains the active substance tolvaptan.

How is Tolvaptan Accord used?

Tolvaptan Accord is given once a day as a tablet. The medicine can only be obtained with a prescription. Treatment should be started in hospital so that healthcare professionals can determine the most appropriate dose and monitor the patient's level of blood sodium and blood volume.For more information about using Tolvaptan Accord, see the package leaflet or contact your doctor or pharmacist.

How does Tolvaptan Accord work?

People with SIADH have an excessive amount of the hormone vasopressin, leading to decreased urine production and an increased amount of water in the blood. The active substance in this medicine, tolvaptan, is a 'vasopressin-2 receptor antagonist'. This means that it blocks one type of receptor (target) to which the hormone vasopressin normally attaches itself. By blocking this receptor, Tolvaptan Accord prevents vasopressin's effect. This increases urine production and decreases the amount of water in the blood, thereby increasing the blood sodium level.Send

How has Tolvaptan Accord 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, Samsca, and do not need to be repeated for Tolvaptan Accord.As for every medicine, the company provided studies on the quality of Tolvaptan Accord. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Tolvaptan Accord?

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

Why is Tolvaptan Accord authorised in the EU?

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

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

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


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Tookad


What is Tookad and what is it used for?

Tookad is a medicine for treating men with low-risk prostate cancer, where the cancer affects only one side of the prostate and patients would normally be expected to survive for at least 10 years.Tookad contains the active substance padeliporfin.

How is Tookad used?

Tookad is given as an injection into a vein over 10 minutes and subsequently activated in the prostate by laser light using a procedure known as vascular-targeted photodynamic (VTP) therapy.During VTP therapy, the patient is put under general anaesthesia so that optical fibres can be inserted into the prostate using hollow needles. Laser light is then shone along the fibres onto the cancer, where it activates the medicine.Tookad can only be used in a hospital by healthcare professionals trained to carry out VTP therapy. The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Tookad work?

Once activated, the active substance in Tookad, padeliporfin, triggers the production of high levels of substances known as oxygen radicals, which cause the destruction of the vessels supplying blood to the cancer followed by rapid death of the cancer cells.

What benefits of Tookad have been shown in studies?

A study of 413 men with low-risk prostate cancer found that Tookad with VTP therapy was effective at clearing signs of prostate cancer in many patients. After 24 months, 49% of patients treated with Tookad had no definitive signs of cancer in their tissues compared with 14% of patients who received no treatment.In addition, Tookad helped delay the progression from low-risk prostate cancer to a higher risk cancer. On average progression occurred after 28 months in patients treated with Tookad compared with 14 months in those who did not receive treatment.

What are the risks associated with Tookad?

The most common side effects with Tookad, which can affect up to 1 in 4 patients, are problems with urinating (pain, inability to pass urine, strong urge to pass urine, frequent urination and incontinence), sexual problems (erectile dysfunction and ejaculation failure), blood in urine, urinary tract infection, and pain and bleeding around the genital area.Other side effects include those related to the general anaesthesia (such as brief memory loss and heart rate abnormalities) and mild liver effects (such as raised liver enzymes). For the full list of side effects reported with Tookad, see the package leaflet.Tookad must not be used in men who have undergone certain procedures on the prostate, men diagnosed with cholestasis (a liver problem) or those with exacerbations (flare-ups) of inflammatory bowel disease. It must also not be used in men who are not suitable for general anaesthesia or invasive procedures, such as VTP therapy. For the full list of restrictions, see the package leaflet.

Why is Tookad approved?

A study found that around half of patients with low-risk prostate cancer treated with Tookad had no definitive signs of the cancer after 2 years. The medicine also doubled the average time it took for a low-risk cancer to progress to a higher risk cancer, which may require more extensive treatment.The side effects seen with Tookad were mainly caused by the insertion of optical fibres during the VTP therapy. Most were mild, resolving within a few days. It is, however, unclear what effect Tookad treatment will have on future treatments for prostate cancer and more study is needed to find out if such treatments are compromised.The European Medicines Agency concluded that the benefits seen with Tookad are greater than its risks and recommended that it be approved for use in the EU.

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

The company that markets Tookad will make educational material available to patients and healthcare professionals to raise awareness of the medicine's risks and provide them with information about VTP therapy.In addition, the company will complete new studies to assess the long-term benefits and safety of the medicine, including any effects of Tookad on future treatments.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tookad have also been included in the summary of product characteristics and the package leaflet.


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Topotecan Hospira


What is Topotecan Hospira?

Topotecan Hospira is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance topotecan.Topotecan Hospira is a 'hybrid medicine'. This means that Topotecan Hospira is similar to a 'reference medicine' already authorised in the European Union (EU). The reference medicine Hycamtin is available as a powder to be made up into a solution for infusion and not as a concentrate.

What is Topotecan Hospira used for?

Topotecan Hospira is used on its own to treat small cell lung cancer, when the cancer has relapsed (come back). It is used when giving the original treatment again is not recommended.It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).The medicine can only be obtained with a prescription.

How is Topotecan Hospira used?

Treatment with Topotecan Hospira should only be given under the supervision of a doctor experienced in the use of chemotherapy. Infusions should be carried out in a specialised cancer ward. The patient's blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, toensure that they are above set minimum levels. The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.The dose of Topotecan Hospira to be used depends on the type of cancer that it is being used to treat and the patient's weight and height. For lung cancer, Topotecan Hospira is given every day for five days with a three-week interval between the start of each course. Treatment may continue until the disease gets worse.When used with cisplatin in cervical cancer, Topotecan Hospira is given on days 1, 2 and 3 (with cisplatin given on day 1). This is repeated every 21 days for six courses or until the disease gets worse.For full details, see the Summary of Product Characteristics (also part of the EPAR).

How does Topotecan Hospira work?

The active substance in Topotecan Hospira, topotecan, is an anticancer medicine that belongs to the group 'topoisomerase inhibitors'. It blocks an enzyme called topoisomerase I, which is involved in the division of DNA. When the enzyme is blocked, the DNA strands break. This prevents the cancer cells from dividing and they eventually die. Topotecan Hospira also affects non-cancer cells, which causes side effects.

How has Topotecan Hospira been studied?

The company has provided data from the published literature on topotecan. No additional studies were needed as Topotecan Hospira is given by infusion and contains the same active substance as the reference medicine, Hycamtin.

What are the benefit and risk of Topotecan Hospira?

Because Topotecan Hospira produces the same levels of the active substance in the body as the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.

Why has Topotecan Hospira been approved?

The CHMP concluded that, in accordance with EU requirements, Topotecan Hospira has been shown to be comparable to Hycamtin. Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk. The Committee recommended that Topotecan Hospira be given marketing authorisation.


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Torisel


What is Torisel and what is it used for?

Torisel is a medicine used to treat patients with the following types of cancer:• advanced renal cell carcinoma (a kidney cancer). 'Advanced' means that the cancer has started to spread;• mantle cell lymphoma (a cancer of B cells, a type of white blood cell). Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.These diseases are rare, and Torisel was designated an 'orphan medicine' (a medicine used in rare diseases) on various dates. Further information on the orphan designations can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (renal cell carcinoma: 6 April 2006, expired November 2017; mantle cell lymphoma: 6 November 2006).Torisel contains the active substance temsirolimus.

How is Torisel used?

Torisel must be given under the supervision of a doctor who has experience in the use of cancer medicines. The medicine can only be obtained with a prescription.Torisel is available as a concentrate and solvent that are made up into a solution for infusion (drip) into a vein. It is given as an infusion lasting 30 to 60 minutes. For renal cell carcinoma, the recommended dose of Torisel is 25 mg once a week, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood. For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.Patients are given an antihistamine injection to prevent an allergic reaction around 30 minutes before each dose of Torisel. Treatment with Torisel should continue until the medicine is no longer working or causes unacceptable side effects. Some side effects can be managed by interrupting treatment or reducing the dose.For more information about using Torisel, see the package leaflet or contact your doctor or pharmacist.

How does Torisel work?

The active substance in Torisel, temsirolimus blocks a protein called 'mammalian target of rapamycin' (mTOR). In the body, temsirolimus attaches to a protein inside cells to make a 'complex'. This complex then blocks mTOR. Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.

What benefits of Torisel have been shown in studies?

Advanced renal cell carcinomaIn advanced renal cell carcinoma, a main study involving 626 patients with poor prognosis found Torisel more effective than interferon alfa (another medicine used in the treatment of cancer) at prolonging patients' survival. Patients were treated with 25 mg Torisel, with interferon alfa or with 15 mg Torisel in combination with interferon alfa. Patients receiving Torisel alone survived 10.9 months on average compared with 7.3 months in those receiving interferon alfa alone. Patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar time (8.4 months) as those taking interferon alfa alone.Mantle cell lymphomaIn mantle cell lymphoma, Torisel was found more effective than alternative cancer medicines (such as gemcitabine or fludarabine) in a main study involving 162 patients whose disease had come back after previous treatment or in whom other treatments had not worked. Each patient received one of two doses of Torisel or the most appropriate alternative cancer medicines chosen by the investigator. The main measure of effectiveness was how long patients lived without the disease getting worse. Patients receiving Torisel lived for 4.8 months on average without their disease getting worse compared with 1.9 months in those receiving the alternative treatment.

What are the risks associated with Torisel?

The most common side effects with Torisel (which may affect more than 1 in 5 patients) include infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia(low red blood cell counts), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), dysgeusia (taste disturbances), difficulty breathing, nose bleeds, cough, vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), rash, pruritus (itching), oedema (swelling), tiredness, weakness, fever and mucosal inflammation (inflammation of moist body surfaces).The most serious side effects of Torisel are allergic (hypersensitivity) reactions, serious reactions that occur during the infusion or soon afterwards, infections, lung disorders including pneumonitis (inflammation of the lungs) and pulmonary embolism (blood clot in the lung), bleeding in the brain, kidney failure, tearing (perforation) of the intestine, complications affecting the healing of wounds, hyperglycaemia (high blood sugar), thrombocytopenia (low levels of platelets), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and hyperlipaemia (high blood levels of a type of fat).For the full list of side effects of Torisel, see the package leaflet.Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejectionof transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine. Torisel must not be used in patients with mantle cell lymphoma who have moderate or severe problems with their liver.

Why is Torisel authorised in the EU?

The European Medicines Agency decided that Torisel'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 Torisel?

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


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Toujeo


What is Toujeo and what is it used for?

Toujeo is a medicine used to control blood glucose (sugar) levels in adults and children from 6 years of age who have diabetes and need insulin.It contains the active substance insulin glargine.

How is Toujeo used?

Toujeo is available as prefilled pens containing a solution for injection of 300 units/ml. It is injected once a day under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that would change the way the insulin is absorbed. The patient's blood glucose should be regularly tested to find the lowest effective dose.Toujeo 300 units/ml must not be used interchangeably with the lower strength insulin glargine (100 units/ml).The medicine can only be obtained with a prescription. For more information about using Toujeo, see the package leaflet or contact your doctor or pharmacist.

How does Toujeo work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Toujeo is a replacement insulin that is very similar to the insulin made by the body.The active substance in Toujeo, insulin glargine, is slightly different from human insulin. The difference means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action. The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.1 Previously known as OptisulinClassified as public by the European Medicines Agency

What benefits of Toujeo have been shown in studies?

The company submitted studies carried out with insulin glargine 100 units/ml.In addition, the effects of Toujeo were compared with those of insulin glargine 100 units/ml in 4 studies involving 3,045 adults with either type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively). In these studies, Toujeo 300 units/ml was comparable to insulin glargine (100 units/ml) at controlling blood glucose levels.Toujeo was also comparable to insulin glargine 100 units/ml at controlling blood glucose levels in a study involving 463 children and adolescents aged 6 to 17 years who had type 1 diabetes.

What are the risks associated with Toujeo?

The most common side effect with Toujeo (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults.For the full list of side effects and restrictions with Toujeo, see the package leaflet.

Why is Toujeo authorised in the EU?

The European Medicines Agency decided that Toujeo's benefits are greater than its risks and it can be authorised for use in the EU.The benefits and safety of insulin glargine in controlling blood glucose level are well established and use of Toujeo allows for a smaller volume to be injected compared with standard insulin, which may be important for patients who require large amounts of insulin.

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

The company that markets Toujeo will provide educational material to healthcare professionals aimed particularly at raising awareness that Toujeo contains insulin that is of a higher strength than standard insulin. The company will also produce educational material for patients on how to use Toujeo correctly, which they should receive from their doctor together with suitable training.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Toujeo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Toujeo are continuously monitored. Side effects reported with Toujeo are carefully evaluated and any necessary action taken to protect patients.


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Tovanor Breezhaler


What is Tovanor Breezhaler and what is it used for?

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

How is Tovanor Breezhaler used?

Tovanor Breezhaler capsules, which contain a powder for inhalation, are only used with the Tovanor Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.The recommended dose is one capsule once a day at the same time each day. Patients should not use more than one capsule in a day.Tovanor Breezhaler can only be obtained with a prescription.For more information about using Tovanor Breezhaler, see the package leaflet or contact your doctor or pharmacist.

How does Tovanor Breezhaler work?

The active substance in Tovanor Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.

What benefits of Tovanor Breezhaler have been shown in studies?

Tovanor Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. In both studies,the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).After 12 weeks of treatment, Tovanor Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.

What are the risks associated with Tovanor Breezhaler?

The most common side effects with Tovanor Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects and restrictions with Tovanor Breezhaler, see the package leaflet.

Why is Tovanor Breezhaler authorised in the EU?

The European Medicines Agency noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. In addition, there were no major safety concerns with Tovanor Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. Therefore, the Agency decided that Tovanor Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.

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

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


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Toviaz


What is Toviaz?

Toviaz is a medicine containing the active substance fesoterodine. It is available as prolonged-release 4 mg tablets and 8 mg tablets. Prolonged-release means that fesoterodine is released slowly from the tablet over a few hours.

What is Toviaz used for?

Toviaz is used in adults with overactive bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination).The medicine can only be obtained with a prescription.

How is Toviaz used?

The recommended starting dose of Toviaz is 4 mg once a day. The tablets are swallowed whole with a glass of water and must not be chewed. The patient normally gets the full effect of the treatment after two to eight weeks. Based upon individual response, the dose may be increased to 8 mg once daily.The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with their kidneys or liver, depending on whether they are also receiving 'CYP3A4 inhibitors', a group of medicines that may affect the way Toviaz is broken down in the body. See the summary of product characteristics (also part of the EPAR) for full details.

How does Toviaz work?

The active substance in Toviaz, fesoterodine, is an anticholinergic medicine. It blocks some receptors in the body, the muscarinic receptors. In the bladder, this causes the muscles that push urine out of the bladder to relax, leading to an increase in the capacity of the bladder and to changes in the way the bladder muscles contract as the bladder fills up. This helps Toviaz to prevent unwanted urination.

How has Toviaz been studied?

The two main studies involved 1,964 patients with overactive bladder syndrome and compared Toviaz (4 or 8 mg a day) with placebo (a dummy treatment). One of the studies also compared Toviaz with tolterodine (another medicine used in overactive bladder syndrome). The main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period after 12 weeks of treatment.

What benefit has Toviaz shown during the studies?

Toviaz was more effective than placebo and as effective as tolterodine in reducing the number of times the patients urinated in a 24-hour period. Before treatment, patients needed to urinate about 12 times in 24 hours. This number was reduced by 1.74 and 1.86 with the 4 mg dose of Toviaz and by 1.94 with the 8 mg dose. The reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69, respectively.

What is the risk associated with Toviaz?

The most common side effect with Toviaz (seen in more than 1 patient in 10) is dry mouth. For the full list of all side effects reported with Toviaz, see the package leaflet.Toviaz must not be used in people who are hypersensitive (allergic) to fesoterodine, to any of the other ingredients, to peanut or to soya. Toviaz must also not be used in patients with:• urinary retention (difficulty in passing urine);• gastric retention (when the stomach does not empty properly);• uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);• myasthenia gravis (a disease of the nerves causing muscle weakness);• severe hepatic impairment (severe liver disease);• severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding);• toxic megacolon (a very serious complication of colitis).Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the same time as strong CYP3A4 inhibitor medicines. These include medicines such as ketoconazole and itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir (medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and nefazodone (used to treat depression).

Why has Toviaz been approved?

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


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Tracleer


What is Tracleer and what is it used for?

Tracleer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms. PAH is abnormally high blood pressure in the arteries of the lungs. The 'class' reflects the severity of the disease:'class III' PAH involves marked limitation of physical activity. The PAH can be:• primary (with no identified cause or inherited);• caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);• caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.Some improvement with Tracleer can also occur in patients with class II PAH. 'Class II' involves slight limitation of physical activity.Tracleer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes). Tracleer is given to reduce the number of new digital ulcers.Tracleer contains the active substance bosentan.

How is Tracleer used?

Tracleer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg).Tracleer is taken morning and evening. In adults, it should be started at a dose of 62.5 mg twice a day for four weeks and then increased to the usual dose of 125 mg twice a day. In children with PAH aged1 year and older, the recommended starting and maintenance dose is 2 mg per kilogram body weight twice a day.Patients should take the film-coated tablets with water. The dispersible tablets are only for use in patients who cannot swallow the film-coated tablets. The dispersible tablets should be mixed with a little water on a spoon before being taken. For more information about using Tracleer, see the package leaflet or contact your doctor or pharmacist.

How does Tracleer work?

The active substance in Tracleer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. Tracleer therefore prevents blood vessels from narrowing.In PAH, severe narrowing of the blood vessels in the lungs increases blood pressure and reduces the amount of blood entering the lungs. By expanding these blood vessels, pressure is reduced and symptoms are improved.In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers. Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers.

What benefits of Tracleer have been shown in studies?

Treatment of PAHIn PAH, Tracleer film-coated tablets added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma. In the larger study patients were able to walk 44 metres further. Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects. There were too few patients with class IV disease to support the use of the medicine in this group.In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Tracleer and placebo groups. However, Tracleer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets.Two additional studies looked at the effects of Tracleer dispersible tablets in children: the first study included 36 children with PAH aged between 2 and 11 years, while the second study included 64 children with PAH aged from 3 months up to 11 years. The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment.Treatment of systemic sclerosis with digital ulcersTracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults. In the first study, patients taking Tracleer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo. Similar resultswere seen in the second study after 24 weeks. The second study which also looked at the effect of Tracleer on digital ulcer healing in 190 patients did not find any effect.

What are the risks associated with Tracleer?

The most common side effects with Tracleer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver. For the full list of side effects Tracleer, see the package leaflet.Tracleer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system). For the full list of restrictions, see the package leaflet.

Why has Tracleer been approved?

The European Medicines Agency decided that Tracleer'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 Tracleer?

The company that makes Tracleer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tracleer have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tracleer are continuously monitored. Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients.


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Tractocile


What is Tractocile?

Tractocile is a solution for injection, and a concentrate that is made up into a solution for infusion (drip into a vein). Both contain the active substance atosiban (7.5 mg per millilitre).

What is Tractocile used for?

Tractocile is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely). These signs include:
• regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
• dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.In addition, the baby must have a normal heart rate.The medicine can only be obtained with a prescription.

How is Tractocile used?

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

How does Tractocile work?

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

How has Tractocile been studied?

The ability of Tractocile to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies. Tractocile was compared with ritodine, terbutaline and salbutamol (allfrom a different class of medicines used in pre-term labour called beta-agonists). The main measure of effectiveness was whether the treatment had worked after a week.

What benefit has Tractocile shown during the studies?

Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342). There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group. The better result with Tractocile over the beta-agonists might have been because it caused fewer side effects, thereby allowing the patients to receive a full course of treatment.

What is the risk associated with Tractocile?

The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick). No side effects have been noted in the newborn baby. For the full list of all side effects reported with Tractocile, see the Package Leaflet.Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients. It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, in women who have premature rupture of the membranes (when the waters break early) after 30 weeks of pregnancy, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the baby or placenta, or when continuing the pregnancy could be dangerous for the mother or baby. For the full list of restrictions, see the Package Leaflet.

Why has Tractocile been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated. The Committee decided that Tractocile's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Trajenta


What is Trajenta?

Trajenta is a medicine that contains the active substance linagliptin. It is available as tablets (5 mg).

What is Trajenta used for?

Trajenta is used to treat type 2 diabetes with the following antidiabetes medicines when blood sugar levels are not already adequately controlled by diet, exercise and these antidiabetes medicines taken alone:• metformin;• metformin and a sulphonylurea;• insulin, either on its own or together with metformin.Trajenta is also used on its own in patients whose blood sugar levels are not adequately controlled by diet and exercise alone and who cannot be treated with metformin because they cannot tolerate it or because they have kidney problems.The medicine can only be obtained with a prescription.

How is Trajenta used?

The recommended dose of Trajenta is one tablet once a day. When added to metformin the dose of metformin should remain unchanged, however when combined with a sulphonylurea or insulin, a lowerdose of the sulphonylurea or insulin may be considered because of the risk of hypoglycaemia (low blood sugar).

How does Trajenta work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Trajenta, 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 does not work when the blood glucose is low. Linagliptin 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.

How has Trajenta been studied?

Five main studies in patients with type 2 diabetes were carried out with Trajenta, comparing the medicine with placebo (a dummy treatment) in combination with metformin (701 patients), in combination with metformin plus a sulphonylurea (1,058 patients), in combination with another antidiabetes medicine pioglitazone (389 patients) and in combination insulin with or without metformin and/or pioglitazone (1235 patients). Trajenta was also compared with placebo when used on its own in 503 patients.In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. This gives an indication of how well blood glucose is controlled.

What benefit has Trajenta shown during the studies?

Trajenta was shown to be more effective than placebo at reducing HbA1c levels in all combinations studied:• when used in combination with metformin, a reduction of 0.56 percentage points was seen with Trajenta compared with a rise of 0.10 percentage points with placebo;• when used in combination with a metformin plus a sulphonylurea, a reduction of 0.72 percentage points was seen with Trajenta compared with a reduction of 0.10 percentage points with placebo;• in combination with pioglitazone, a reduction of 1.25 percentage points was seen with Trajenta compared with a reduction of 0.75 percentage points with placebo;• in combination with insulin with or without metformin and/or pioglitazone, a reduction of 0.55 percentage points was seen with Trajenta compared with a rise of 0.10 percentage points with placebo.Trajenta was also more effective than placebo when used on its own, reducing HbA1c levels by 0.46 percentage points compared with a rise of 0.22 percentage points seen with placebo.

What is the risk associated with Trajenta?

Results from studies show that the overall risk of side effects were similar between Trajenta and placebo: (63% versus 60%). The most frequently reported side effect, seen in around 6 out of 100 patients taking Trajenta, was hypoglycaemia. Most cases were mild and none were severe.Hypoglycaemia was seen in around 15 out of 100 patients treated with the triple combination of Trajenta with metformin and a sulphonylurea (around twice as many as the placebo group). For the full list of all side effects reported with Trajenta, see the package leaflet.Trajenta must not be used in people who are hypersensitive (allergic) to linagliptin or to any of the other ingredients.

Why has Trajenta been approved?

Based on the results of the main studies, the CHMP concluded that significant benefits in controlling blood glucose levels were seen in the combinations of Trajenta with metformin, with metformin plus a sulphonylurea, and with insulin with or without metformin. Trajenta on its own was also shown to be effective compared with placebo and was considered appropriate for patients who cannot take metformin either due to intolerance or because they have kidney problems. However the benefit of adding Trajenta to pioglitazone treatment was not considered to have been sufficiently established.The overall risk of side effects with Trajenta was mostly comparable to placebo and the medicine's safety is similar to that of other dipeptidyl peptidase 4 (DPP-4) inhibitor medicines.The Committee therefore concluded that the benefits of Trajenta outweigh its risks and recommended that it be granted marketing authorisation.


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Translarna


What is Translarna and what is it used for?

Translarna is a medicine that is used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk. Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function. Translarna is used in the small group of patients whose disease is caused by a specific genetic defect (called a 'nonsense mutation') in the dystrophin gene.Duchenne muscular dystrophy is rare, and Translarna was designated an 'orphan medicine' (a medicine used in rare diseases) on 27 May 2005. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation

How is Translarna used?

Translarna can only be obtained with a prescription and treatment should be started by a specialist doctor experienced in the management of Duchenne/Becker muscular dystrophy.Before starting treatment with Translarna, patients will have a genetic test to confirm that their disease is due to a nonsense mutation and that they are therefore suitable for treatment with Translarna.Translarna is available as granules (125, 250 and 1,000 mg) to be taken by mouth after mixing them with liquid or semi-solid food (such as yogurt). Translarna is taken three times a day, and the recommended dose is 10 mg/kg (10 mg per kilogram body weight) in the morning, 10 mg/kg at midday and 20 mg/kg in the evening (making a total daily dose of 40 mg/kg).For more information about using Translarna, see the package leaflet or contact a doctor or pharmacist.

How does Translarna work?

Patients with Duchenne muscular dystrophy lack normal dystrophin, a protein found in muscles. Because this protein helps to protect muscles from injury as muscles contract and relax, in patients with Duchenne muscular dystrophy the muscles become damaged and eventually stop working.Duchenne muscular dystrophy can be caused by a number of genetic abnormalities. Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene which prematurely stop the production of a normal dystrophin protein, leading to a shortened dystrophin protein that does not function properly. Translarna works in these patients by enabling the protein-making apparatus in cells to move past the defect, allowing the cells to produce a functional dystrophin protein.

What benefits of Translarna have been shown in studies?

In one main study, involving 174 patients aged 5 to 20 years with Duchenne muscular dystrophy who were able to walk, two doses of Translarna (40 mg/kg daily and 80 mg/kg daily) were compared with placebo (a dummy treatment). The main measure of effectiveness was the change in the distance the patient could walk in six minutes after 48 weeks of treatment.Although an initial analysis of the results of all the data from the study did not show a significant difference in the distances patients in the Translarna and placebo groups could walk, further analyses indicated that walking ability worsened to a lesser extent with 40 mg/kg daily Translarna than with placebo: after 48 weeks of treatment patients receiving 40 mg/kg daily Translarna could walk on average 32 metres more than those given placebo. The effect was more pronounced in a subgroup of patients whose ability to walk was worsening, where patients taking 40 mg/kg daily Translarna could walk on average 50 metres more than those taking placebo. The beneficial effect of the lower dose was also supported by improvements in other measures of effectiveness, including those directly linked to patients' daily activities. No improvement was seen with the higher dose (80 mg/kg daily).A further study in 230 patients aged 7 to 14 years with worsening walking ability was completed after initial approval, but its results were considered inconclusive. However, data indicated that Translarna had a positive effect on different measures such as time to run or walk 10 metres, time to climb up and down 4 steps and time to loss of walking ability. In both studies, the beneficial effects of Translarna seemed more evident in patients with moderate decline of their disease.A small study in children aged 2 to 5 years with Duchenne muscular dystrophy found that the usual dose of Translarna 40 mg/kg daily was sufficient. Translarna seemed effective on an assessment of physical activity in 12 patients when compared with past records of 11 patients of similar age who had not been treated with Translarna.

What are the risks associated with Translarna?

The most common side effects with Translarna (which may affect more than 5 in 100 people) are vomiting, diarrhoea, nausea (feeling sick), headache, stomach ache and flatulence.Translarna must not be used at the same time as aminoglycoside antibiotics given by injection or infusion (drip) into a vein.For the full list of side effects and restrictions of Translarna, see the package leaflet.

Why is Translarna authorised in the EU?

The European Medicines Agency decided that Translarna's benefits are greater than its risks and it can be authorised for use in the EU.Despite the need for further data, the Agency considered that the evidence suggests that Translarna slows the progression of the disease and that its safety profile is not of major concern. The Agencyacknowledged that patients with Duchenne muscular dystrophy have an unmet need for treatment of this serious condition.Translarna has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Translarna?

Since Translarna has been given conditional authorisation, the company that markets it will provide results of a new study comparing Translarna with placebo in order to confirm its effectiveness and safety.

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

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


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Travatan


What is Travatan?

Travatan is a clear eye drop solution that contains the active substance travoprost.

What is Travatan used for?

Travatan is used to reduce intraocular pressure (pressure inside the eye). It is used in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal). It can also be used in children from two months of age who have ocular hypertension or childhood glaucoma.The medicine can only be obtained with a prescription.

How is Travatan used?

The dose is one drop of Travatan in the affected eye(s) once a day, preferably in the evening.If other eye drops are also being used, they should be given at least 5 minutes apart.

How does Travatan work?

When intraocular pressure is raised, it 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, Travatan reduces the risk ofdamage. The active substance in Travatan, travoprost, is a prostaglandin analogue (a man-made copy of a prostaglandin, one of a group of substances naturally found in the body). In the eye, prostaglandins increase the drainage of the watery fluid (aqueous humour) out of the eyeball. Travatan acts in the same way and increases the flow of fluid out of the eye. This helps to reduce the pressure inside the eye.

How has Travatan been studied?

Travatan has been studied in 1,989 adult patients in three main studies, lasting between six and 12 months. All three studies compared travoprost with timolol, which is the standard treatment for glaucoma. One of the three trials also included a comparison with latanoprost (another prostaglandin analogue used for glaucoma). . A fourth study also compared the effectiveness of adding Travatan to treatment with timolol (427 patients, six-month duration). In addition, Travatan was compared with timolol in a fifth main study over 3 months, involving 152 children between 2 months and 18 years of age. The main measure of effectiveness in all studies was the reduction in intraocular pressure

What benefit has Travatan shown during the studies?

Travatan was at least as effective as timolol and as effective as latanoprost in reducing intraocular pressure. The combined treatment with Travatan plus timolol produced an additional decrease of intraocular pressure in patients who were not controlled with timolol alone.

What is the risk associated with Travatan?

The most common side effects when using Travatan (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to eye irritation and redness) and iris hyperpigmentation (darkening of the colour of the iris). There may also be changes to the patient's eyelashes, including increased length, thickness, colour or number of lashes. Side effects reported in children are similar to those seen in adults. For the full list of all side effects and restrictions with Travatan, see the package leaflet.

Why has Travatan been approved?

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


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Trazimera


What is Trazimera and what is it used for?

Trazimera is a cancer medicine used to treat the following conditions:• early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Trazimera is used before surgery in combination with chemotherapy and then again after surgery on its own;• metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own when other treatments have not worked or are not suitable. It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;• metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).Trazimera can only be used when the cancer 'overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.Trazimera is a 'biosimilar medicine'. This means that Trazimera is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Trazimera is Herceptin. For more information on biosimilar medicines, see here.Trazimera contains the active substance trastuzumab.

How is Trazimera used?

Trazimera can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer. For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective. The dose depends on the patient's body weight, on the condition being treated and on whether Trazimera is given every week or every 3 weeks.The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion. Patients who do not have significant reactions to the first 90-minute infusion can receive subsequent infusions over 30 minutes.For more information about using Trazimera, see the package leaflet or contact a doctor or pharmacist.

How does Trazimera work?

The active substance in Trazimera, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 from producing signals that cause the tumour cells to grow.

What benefits of Trazimera have been shown in studies?

Laboratory studies comparing Trazimera with Herceptin have shown that the active substance in Trazimera is highly similar to that in Herceptin in terms of structure, purity and biological activity. Studies have also shown that giving Trazimera produces similar levels of the active substance in the body to giving Herceptin.In addition, a main study involving 707 patients with metastatic breast cancer that overexpressed HER2 showed that Trazimera was as effective in treating the condition as Herceptin. In this study, 63% of patients given Trazimera had a complete or partial response to treatment compared with 67% of those given Herceptin.Because Trazimera is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Trazimera.

What are the risks associated with Trazimera?

The most common or serious side effects with Trazimera are heart problems, reactions related to the Trazimera infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.Trazimera can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should). Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.Trazimera must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients. It must not be used in patients whose advanced cancer causes serious breathing problems even when resting, or who need oxygen therapy.For the full list of side effects and restrictions, see the package leaflet.

Why is Trazimera authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Trazimera has been shown overall to have a comparable quality, safety and effectiveness to Herceptin. Therefore, the Agency's view was that, as for Herceptin, the benefit of Trazimera outweighs the identified risk and it can be authorised.

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

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


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Trecondi


What is Trecondi and what is it used for?

Trecondi is a medicine given to patients before they have a bone marrow transplant from a donor known as 'allogeneic haematopoietic stem cell transplantation'. It is used as a 'conditioning' treatment to clear the patient's bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells.Trecondi is used together with a medicine called fludarabine in adults and children from 1 month of age with blood cancers or other severe disorders requiring a bone marrow transplant.The active substance in Trecondi is treosulfan.Haematopoietic stem cell transplantation is rare, and Trecondi was designated an 'orphan medicine' (a medicine used in rare diseases) on 23 February 2004. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu304186.

How is Trecondi used?

Trecondi is given as a two-hour infusion (drip) into a vein. The patient receives Trecondi once a day for 3 days before the transplantation. Fludarabine is given once a day for 5 days before transplantation.The medicine can only be obtained with a prescription and the use of Trecondi must be supervised by a doctor experienced in conditioning treatment before allogeneic haematopoietic stem cell transplantation.For more information about using Trecondi, see the package leaflet or contact your doctor or pharmacist.

How does Trecondi work?

The active substance in Trecondi, treosulfan, belongs to a group of medicines called alkylating agents. In the body, treosulfan is converted into other compounds called epoxides which kill cells, especially cells that develop rapidly such as bone marrow cells. Epoxides act by attaching to the DNA of cellswhile they are dividing. By doing so, Trecondi can kill cells in the patient's bone marrow and make room for the new cells from a donor.

What benefits of Trecondi have been shown in studies?

Three main studies showed that Trecondi is at least as effective as busulfan, another medicine used to prepare patients for haematopoietic stem cell transplantation.In one of the studies, involving 570 adults with acute myeloid leukaemia (a blood cancer) or myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced), 64% of patients given Trecondi (with fludarabine) had a successful transplant and were alive and disease-free after 2 years, compared with 51% of patients given busulfan (with fludarabine).In another study involving 70 children with blood cancers, 99% of the children given Trecondi (with fludarabine) were alive 3 months after their transplant; 91% of the children were alive after one year and 84% after three years.In an additional study involving 101 children with other severe disorders requiring a bone marrow transplant, none of the 51 children given Trecondi had died from causes related to transplantation in the 3 months after the procedure, compared with 5 out of 50 children given busulfan (with fludarabine). One year after the transplant, 96% of the children given Trecondi and 88% of those given busulfan were alive.

What are the risks associated with Trecondi?

The most common side effects in adults and children with Trecondi (which may affect more than 1 in 10 people) are infections, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), vomiting, and diarrhoea. Tiredness, febrile neutropenia (low white blood cell counts with fever) and high blood levels of bilirubin (a breakdown product of red blood cells) are also seen in more than 1 in10 adults, and liver toxicity and an increase in blood levels of certain liver enzymes, abdominal pain (belly ache), itching and fever may also affect more than 1 in 10 children.Common side effects in adults (which may affect more than 1 in 100 people) are abdominal pain, decreased appetite, rash, itching, hair loss, fever, oedema (swelling due to fluid retention), and an increase in blood levels of certain liver enzymes. Common side effects in children (which may affect more than 1 in 100 people) are tiredness, febrile neutropenia, rash, hair loss, and high blood levels of bilirubin.Trecondi must not be used in patients with an active, uncontrolled infection, with severe heart, lung, liver or kidney problems, and in patients with Fanconi anaemia and other DNA repair disorders. Pregnant women must not use Trecondi and live vaccines must not be given to patients receiving Trecondi.For the full list of side effects and restrictions, see the package leaflet.

Why is Trecondi authorised in the EU?

Trecondi is effective at preparing adults and children for haematopoietic stem cell transplantation.Side effects with Trecondi are manageable and comparable to those seen with busulfan. Like busulfan, Trecondi is considered as a conditioning treatment of 'reduced-intensity': this means that it is less toxic than standard conditioning treatments which are based on chemotherapy with or without radiation.The European Medicines Agency therefore decided that Trecondi'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 Trecondi?

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


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Trelegy Ellipta


What is Trelegy Ellipta and what is it used for?

Trelegy Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.Trelegy Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist. Long-acting beta-2 agonists widen the airways; corticosteroids reduce inflammation in the airways and lungs; and muscarinic receptor antagonists cause the muscles of the airways to relax.Trelegy Ellipta is used for maintenance (regular) treatment on a daily basis. It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.

How is Trelegy Ellipta used?

Trelegy Ellipta can only be obtained with a prescription. It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day. For more information about using Trelegy Ellipta, see the package leaflet or contact your doctor or pharmacist.

How does Trelegy Ellipta work?

Trelegy Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.Fluticasone furoate is a corticosteroid. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells. This reduces the release of substances involved in the inflammation process, such as histamine, thereby reducing inflammation and helping to keep the airways clear and allowing the patient to breathe more easily.Umeclidinium bromide is a muscarinic receptor antagonist. It works by blocking muscarinic receptors, which are involved in the contraction of muscles. When umeclidinium bromide is inhaled, it causes the muscles of the airways to relax.Vilanterol is a long-acting beta-2 agonist. It works by attaching to beta-2 receptors in some types of muscle cells. When inhaled, vilanterol activates the beta-2 receptors in the airways. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

What benefits of Trelegy Ellipta have been shown in studies?

Trelegy Ellipta was shown to improve patients' breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.A study compared Trelegy Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.In this study, Trelegy Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Trelegy Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.After 24 weeks, patients taking Trelegy Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml. This compares with an average reduction of 29 ml seen in patients taking the combination of budesonide and formoterol over the same period. Patients treated with Trelegy Ellipta also reported improved health compared with those treated with the comparator treatment.

What are the risks associated with Trelegy Ellipta?

The most common side effects with Trelegy Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection). More serious side effects include pneumonia (which may affect up to 1 in 10 people).For the full list of side effects and restrictions with Trelegy Ellipta, see the package leaflet.

Why is Trelegy Ellipta authorised in the EU?

Trelegy Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD. Regarding the safety profile of the medicine, the most frequent side effects reported with Trelegy Ellipta were similar to those with the individual active substances of the medicine and are well known. The European Medicines Agency therefore decided that Trelegy Ellipta'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 Trelegy Ellipta?

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


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Tremelimumab Astrazeneca


What is Tremelimumab AstraZeneca and what is it used for?

Tremelimumab AstraZeneca is a cancer medicine for treating non-small cell lung cancer (NSCLC) that has metastasised (spread to other parts of the body) in adults who have not been treated before. It is given together with durvalumab (another cancer medicine) and platinum-based chemotherapy, and is used when the cancer has shown no mutations (changes) in the so-called EGFR and ALK genes.Tremelimumab AstraZeneca contains the active substance tremelimumab.

How is Tremelimumab AstraZeneca used?

Tremelimumab AstraZeneca can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in treating cancer.Tremelimumab AstraZeneca is given as an infusion (drip) into a vein which lasts about an hour, in combination with durvalumab and chemotherapy. Treatment consists of a maximum of 5 doses, but may be stopped permanently if the cancer worsens or if the patient gets severe side effects.For more information about using Tremelimumab AstraZeneca, see the package leaflet or contact your doctor or pharmacist.

How does Tremelimumab AstraZeneca work?

The active substance in Tremelimumab AstraZeneca, tremelimumab, is a monoclonal antibody (a type of protein). It is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system (the body's natural defences). By blocking CTLA-4, the medicine increases the number and activity of T cells, which can then kill cancer cells. This is expected to slow down the spread of the cancer.

What benefits of Tremelimumab AstraZeneca have been shown in studies?

In a main study in patients with metastatic NSCLC, 338 patients given Tremelimumab AstraZeneca in combination with durvalumab and chemotherapy lived on average for 14 months, compared with 12 months for 337 patients given only chemotherapy. They also lived longer without their disease gettingworse: around 6 months on average, compared with 5 months for patients who only received chemotherapy.

What are the risks associated with Tremelimumab AstraZeneca?

The most common side effects with Tremelimumab AstraZeneca in combination with durvalumab and chemotherapy (which may affect more than 2 in 10 people) are anaemia (low levels of red blood cells), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), tiredness, rash, thrombocytopenia (low levels of platelets in the blood) and diarrhoea.The most common serious side effects (which may affect more than 2 in 10 people) are neutropenia and anaemia. Other serious side effects (which may affect up to 1 in 10 people) are pneumonia (infection of the lungs), thrombocytopenia, leucopenia (low levels of white blood cells), tiredness, neutropenia with fever, colitis (inflammation of the large intestine) and increased levels of liver enzymes and lipase (an enzyme that helps digest fat, mainly made in the pancreas).Tremelimumab AstraZeneca is commonly associated with side effects related to the activity of the immune system on body organs, such as immune-mediated hypothyroidism (an underactive thyroid gland) and colitis.For the full list of side effects and restrictions of Tremelimumab AstraZeneca, see the package leaflet.

Why is Tremelimumab AstraZeneca authorised in the EU?

Tremelimumab AstraZeneca, when given in combination with durvalumab and chemotherapy, can prolong patients' lives compared with chemotherapy only. Side effects of added Tremelimumab AstraZeneca, in particular concerning immune-mediated side effects, can be serious, and warrant caution when treating frail or elderly patients.The European Medicines Agency decided that Tremelimumab AstraZeneca'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 Tremelimumab AstraZeneca?

The company that markets Tremelimumab AstraZeneca must provide healthcare professionals prescribing the medicine with educational materials on the side effects resulting from excessive activity of the immune system. Patients will also receive from their doctor an alert card summarising key safety information on the medicine.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tremelimumab AstraZeneca have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tremelimumab AstraZeneca are continuously monitored. Suspected side effects reported with Tremelimumab AstraZeneca are carefully evaluated and any necessary action taken to protect patients.


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Tremfya


What is Tremfya and what is it used for?

Tremfya is a medicine used to treat moderate to severe plaque psoriasis (a disease causing red, scaly skin patches) when treatments applied to the skin are not suitable.It is also used to treat psoriatic arthritis (scaly skin patches with joint inflammation) alone or with another medicine called methotrexate. For psoriatic arthritis, Tremfya is used when medicines to treat the underlying inflammation (disease-modifying medicines) have not worked well enough or when the patient cannot take these medicines.Tremfya contains the active substance guselkumab.

How is Tremfya used?

Tremfya can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating the conditions for which Tremfya is used.Tremfya is available as an injection in pre-filled syringes or pens. It is injected under the skin in an area that is clear of psoriasis. The recommended dose is 100 mg, followed by a further dose after 4 weeks and then 100 mg every 8 weeks. For patients with psoriatic arthritis who have a high risk of joint damage, the doctor may decide that it can be injected every 4 weeks. The doctor may stop treatment if the condition does not improve after 16 or 24 weeks.After training, patients may inject Tremfya themselves if the doctor considers it appropriate.For more information about using Tremfya, see the package leaflet or contact your doctor or pharmacist.

How does Tremfya work?

The active substance in Tremfya, guselkumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity. Interleukin 23 is a messenger substance that controls the growth and maturation of some types of T cells. These T cells, which are part of the body's immune system (the body's natural defences), are involved in causing inflammation that is linked toplaque psoriasis and psoriatic arthritis. By blocking the action of interleukin 23, guselkumab reduces inflammation and other symptoms of the disease.

What benefits of Tremfya have been shown in studies?

Plaque psoriasisThree main studies involving 2,700 adults found Tremfya effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough. A main measure of effectiveness was a reduction of at least 90% in PASI scores. PASI is a measure of disease severity and area of skin affected.The first two studies compared Tremfya with adalimumab (another medicine used for treating psoriasis) and placebo (a dummy treatment). After 16 weeks, about 71% of patients (588 out of 825) receiving Tremfya had a reduction of at least 90% in PASI scores, compared with 48% (282 out of 582) of those receiving adalimumab and under 3% (11 out of 422) receiving placebo. Improvement in psoriasis symptoms was maintained beyond 48 weeks with Tremfya treatment.The third study involved 871 patients who were treated with ustekinumab (another medicine used for treating psoriasis). Patients whose psoriasis did not improve sufficiently after 16 weeks either received Tremfya or continued treatment with ustekinumab for at least 24 weeks. During this period, symptoms of psoriasis improved to a greater extent in patients receiving Tremfya than in those remaining on ustekinumab.Psoriatic arthritisA study looked at the effect of Tremfya in 381 patients with psoriatic arthritis for whom standard treatments did not work. Around 52% of those treated with Tremfya every 8 weeks and 59% of those treated with Tremfya every 4 weeks had a 20% improvement in a symptom score (called ACR20) after 24 weeks. This compared with 22% of those receiving placebo.In another study, involving 739 patients, 64% of patients receiving Tremfya every 8 or 4 weeks had a 20% improvement in symptom score after 24 weeks, compared with 33% of those receiving placebo.

What are the risks associated with Tremfya?

The most common side effects with Tremfya (which may affect more than 1 in 10 people) are infections in the nose and throat.Tremfya must not be used in patients who have an infection that the doctor considers important.For the full list of side effects and restrictions, see the package leaflet.

Why is Tremfya authorised in the EU?

The European Medicines Agency decided that Tremfya's benefits are greater than its risks in the treatment of moderate and severe plaque psoriasis and psoriatic arthritis and that it can be authorised for use in the EU.The Agency considered that Tremfya is effective and longer-term studies for plaque psoriasis have shown that it remains effective with continued use. It improved physical function and quality of life in patients with psoriatic arthritis. Long-term safety data have shown that it has few side effects. Patients are likely to continue treatment with Tremfya because it can be injected every 8 weeks (after the first 4 weeks) and patients can inject it themselves, making it convenient to use.Tremfya Tremfya (guselkumab)

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

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


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Trepulmix


What is Trepulmix and what is it used for?

Trepulmix is a medicine for use in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH), a condition linked with high blood pressure in the lungs caused by blood clots. It can be used to improve the capacity for physical activity in patients:• who cannot have an operation for treating the condition;• whose condition remains or continues to return after an operation to treat it.CTEPH is rare, and Trepulmix was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 February 2013. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3131103.Trepulmix is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but it is used for treating a different form of pulmonary hypertension. The reference medicine for Trepulmix is Remodulin.Trepulmix contains the active substance treprostinil.

How is Trepulmix used?

Trepulmix is given by infusion (drip) under the skin using a pump to control the speed of infusion. The dose is calculated on the basis of the patient's weight and is adjusted according to how well the condition is controlled and the severity of any side effects. The patient will be trained on using the pump and on infusing the medicine.The medicine can only be obtained with a prescription and treatment with Trepulmix should be started and monitored only by healthcare professionals experienced in treating pulmonary hypertension.Treatment should be started in a setting where intensive care facility is available.For more information about using Trepulmix, see the package leaflet or contact your doctor or pharmacist.Send us a quest

How does Trepulmix work?

Treprostinil, the active substance in Trepulmix, works in a similar way to prostacyclin, a natural substance that widens blood vessels and stops platelets (blood components) from sticking to each other to form blood clots. In patients with CTEPH, these effects of treprostinil prevent blood clots and lower blood pressure in the pulmonary artery and so improve symptoms of the disease.

What benefits of Trepulmix have been shown in studies?

A main study involving 105 patients with severe CTEPH who could not have an operation found that Trepulmix can improve patients' capacity for physical activity, measured as the ability to walk.In this study, patients received Trepulmix at a high dose (30 nanograms/kg/minute) or low dose (3 nanograms/kg/minute) which was not expected to have an effect. After 24 weeks, patients receiving the high dose were able to walk an average of 45 metres further in 6 minutes than at the start of treatment, compared with 4 metres further for those receiving the low dose.Additional studies including comparison with records of patients with CTEPH who had not been treated with Trepulmix confirmed improvement in physical capacity.

What are the risks associated with Trepulmix?

The most common side effects with Trepulmix (which may affect more than 1 in 10 people) are headache, widening of blood vessels (with flushing), diarrhoea, nausea (feeling sick), jaw pain, reactions around the injection site such as pain, swelling and bleeding.Trepulmix must not be used in patients with conditions like heart problems, stroke, problems in the gut such as ulcers, blocked veins in lungs and severe liver problems. Patients must not take Trepulmix at the same time as similar medicines called prostanoids.For the full list of side effects and restrictions of Trepulmix, see the package leaflet.

Why is Trepulmix authorised in the EU?

The main study found that Trepulmix increases the distance patients can walk in 6 minutes. Although this study was small (because of the rarity of the disease), the results were meaningful. Additional studies showed that Trepulmix improved blood circulation and patients' physical capability.Side effects are those expected from the way Trepulmix works and are manageable. The European Medicines Agency therefore decided that Trepulmix'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 Trepulmix?

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


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Tresiba


What is Tresiba?

Tresiba is a medicine that contains the active substance insulin degludec. It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml and 200 units/ml).

What is Tresiba used for?

Tresiba is used to treat type 1 and type 2 diabetes in adults and children aged 1 to 18 years of age.The medicine can only be obtained with a prescription.

How is Tresiba used?

Tresiba is injected once a day, preferably at the same time every day. It is given as an injection under the skin in the thigh, upper arm or abdominal wall (at the front of the waist). The place within the chosen area should be changed with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of insulin absorbed.The correct dose is determined individually for each patient. In type 1 diabetes, Tresiba must always be used in combination with rapid acting insulin, which is injected at mealtimes. In type 2 diabetes, Tresiba can be used alone or in combination with diabetes medicines given by mouth, GLP-1 receptor agonist medicines and rapid acting mealtime insulin.

How does Tresiba work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively. Tresiba is a replacement insulin that is very similar to the natural insulin with a difference that it is absorbed more slowly in the body and takes longer to reach its target. This means that Tresiba has a long duration of action. Tresiba acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Tresiba been studied?

Tresiba has been studied in three main studies involving 1,578 adults with type 1 diabetes, where Tresiba (in combination with rapid acting mealtime insulin) was compared with insulin glargine or insulin detemir (other long acting insulins).Six other main studies involving 4,076 adults with type 2 diabetes compared Tresiba with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type 2 diabetes). Patients in these studies could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed. Another main study involving 177 adults with type 2 diabetes investigated the effectiveness of combining Tresiba and liraglutide (a GLP-1 receptor agonist).In addition Tresiba was compared with insulin detemir in one main study involving 350 children aged 1 to 18 years of age with type 1 diabetes. Patients were also given rapid-acting insulin at mealtimes. After 26 weeks of treatment, patients had the option to either stop treatment or continue with it for up to a year.All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose. HbA1c gives an indication of how well the blood glucose is controlled. Studies lasted for six months or one year.

What benefit has Tresiba shown during the studies?

The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in adults with type 1 and type 2 diabetes, and more effective than sitagliptin in adults with type 2 diabetes. Across the studies, the average reduction in HbA1c levels with Tresiba treatment was 0.6 percentage points in adults with type 1 diabetes and 1.2 points in adults with type 2diabetes.In children, the effects of Tresiba on blood glucose control were similar to those of insulin detemir.After 26 weeks of treatment with Tresiba, the average reduction in HbA1c was 0.2 percentage points (HbA1c decreased from 8.2% to 8.0%) compared with a reduction of 0.3 percentage points with insulin detemir (HbA1c decreased from 8.0% to 7.7%).

What is the risk associated with Tresiba?

The most frequently reported side effect during treatment with Tresiba (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).For the full list of side effects and restrictions with Tresiba, see the package leaflet.

Why has Tresiba been approved?

The CHMP concluded that Tresiba is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes. Regarding its safety, the Committee concluded that Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported. It also noted that Tresiba reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2 diabetes. The CHMP noted that the higher strength formulation of Tresiba met a medical need for patients requiring higher dose insulin (such as overweight patients), which would allow these patients to take their daily dose in a single injection rather than two injections. For adolescents with type 2 diabetes, the CHMP concluded that although safety and effectiveness had only been shown for type 1 diabetes, the results of studies carried out in adolescents with type 1 and other studies in adults with type 2 diabetes could be applied to adolescents with type 2. The CHMP decided that Tresiba'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 Tresiba?

A risk management plan has been developed to ensure that Tresiba 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 Tresiba, including the appropriate precautions to be followed by healthcare professionals and patients.The company that markets Tresiba will provide educational materials to healthcare professionals expected to treat or dispense medicines to patients with diabetes, aimed particularly at raising awareness of the higher strength formulation of Tresiba in order to ensure that the patient is prescribed the correct strength. It will also produce educational materials for patients on how to use Tresiba correctly, which they should receive through their doctor together with suitable training.


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Trevicta


What is Trevicta and what is it used for?

Trevicta is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has been stable on treatment with once-monthly injections of paliperidone. The symptoms of schizophrenia include disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).Trevicta contains the active substance paliperidone.

How is Trevicta used?

Trevicta is available as a prolonged-release suspension for injection in pre-filled syringes (175 mg, 263 mg, 350 mg and 525 mg). Prolonged-release means that the active substance, paliperidone, is released slowly over a few months after being injected. The medicine can only be obtained with a prescription.Trevicta is given by a healthcare professional. It is given every 3 months by slow injection into the upper part of the shoulder (deltoid muscle) or the buttocks. The dose of Trevicta is 3.5 times the dose of the monthly injections of paliperidone the patient was previously receiving.For more information on the use of Trevicta, see the summary of product characteristics (also part of the EPAR).1 Previously known as Paliperidone Janssen.

How does Trevicta work?

The active substance in this medicine, paliperidone, is an antipsychotic medicine. Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s. In the brain, paliperidone attaches to several different receptors on the surface of nerve cells. This disrupts signals transmitted between brain cells by 'neurotransmitters', substances that nerve cells use to communicate with neighbouring cells. Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin). By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms of the disease.Paliperidone has been authorised in the European Union (EU) as Invega since 2007 for use by mouth to treat schizophrenia. It has also been authorised as Xeplion since 2011 for use by monthly injections for the maintenance treatment of schizophrenia. In Trevicta as in Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected. This gives the medicine a long duration of action.

What benefits of Trevicta have been shown in studies?

Two studies have been conducted with Trevicta given every 3 months. In one of them (involving 1,016 patients) Trevicta was as effective as paliperidone monthly injections in preventing relapses of schizophrenia. In the second study (in 305 patients) Trevicta was more effective than placebo (a dummy treatment), with 9% of patients given the medicine suffering a relapse of their condition compared with 29% of those on placebo.Because paliperidone for use by monthly injections has already been authorised in the EU as Xeplion, the company also used data from Xeplion to support the use of Trevicta.

What are the risks associated with Trevicta?

The most common side effects with Trevicta (seen in at least 5 in 100 patients) are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infections (such as colds), reactions at the site of injection and increased weight.For the full list of all side effects reported with Trevicta, see the package leaflet.Trevicta must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.

Why is Trevicta approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that paliperidone injections are effective in treating schizophrenia symptoms. Trevicta, which is given by injection every 3 months, is more effective than placebo and as effective as paliperidone monthly injection in preventing relapses of schizophrenia. The 3-monthly injection is expected to be more convenient to patients and improve their adherence to treatment, and no new safety concerns were raised with this formulation compared with the known safety profile of paliperidone. The Committee therefore decided that Trevicta's benefits are greater than its risks and recommended that it be given marketing authorisation.Trevicta0F

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

A risk management plan has been developed to ensure that Trevicta 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 Trevicta, 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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Trimbow


What is Trimbow and what is it used for?

Trimbow is a medicine used in adults for treating moderate to severe chronic obstructive pulmonary disease (COPD) and asthma.In COPD, Trimbow is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two medicines consisting of a longacting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist. Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.In asthma, Trimbow is used for maintenance treatment in adults whose disease is not adequately controlled despite treatment with a long-acting beta-2 agonist plus a medium or high dose of inhaled corticosteroid, and who had one or more exacerbations (flare-ups) in the past year.Trimbow contains the active substances beclometasone, formoterol and glycopyrronium bromide.

How is Trimbow used?

Trimbow is available as a liquid in a portable inhaler device. Patients should take two inhalations twice a day. Trimbow is available in two strengths. The doctor will decide which strength the patient should use based on whether Trimbow is used for asthma or for COPD, and, for asthma, on whether patients had been using a medium or high dose of inhaled corticosteroid.Patients should be shown how to use the inhaler correctly by a doctor or another healthcare professional, who should also regularly check that the patient's inhalation technique is correct.The medicine can only be obtained with a prescription. For more information about using Trimbow, see the package leaflet or contact your doctor or pharmacist.

How does Trimbow work?

The three active substances in Trimbow work in different ways to reduce inflammation and keep theairways open, allowing the patient to breathe more easily.Beclometasone belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system. This leads to a reduction in the release of substances involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. It opens the airways by blocking muscarinic receptors in muscle cells in the lungs. Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.

What benefits of Trimbow have been shown in studies?

COPDTrimbow has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a long-acting muscarinic receptor antagonist alone.In the first study lasting a year, after 26 weeks of treatment Trimbow improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose. By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Trimbow (beclometasone plus formoterol).In the second study lasting a year, patients treated with Trimbow had 20% fewer exacerbations (flareups of symptoms) a year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist). In this study, Trimbow was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.In the third study lasting a year, patients treated with Trimbow had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.AsthmaA main study involved over 1,000 patients with asthma whose disease was not adequately controlled on medium doses of inhaled corticosteroids in combination with long-acting beta-2 agonists. Patients had at least one asthma exacerbation in the previous year. After 26 weeks of treatment, Trimbow (medium strength) improved patients' FEV1 before dosing by 185 ml compared with 127 ml with a combination of beclometasone plus formoterol. In addition, patients treated with Trimbow for up to one year had 15% fewer moderate and severe exacerbations a year than patients treated with beclometasone plus formoterol.In a second study in over 1,000 patients with asthma whose disease was not adequately controlled on high doses of inhaled corticosteroids in combination with long-acting beta-2 agonists, Trimbow (higher strength) improved patients' FEV1 before dosing by 229 ml compared with 157 ml for beclometasone plus formoterol after 26 weeks of treatment. The 12% reduction in the yearly rate of moderate tosevere exacerbations was not statistically different (meaning that it may be due to chance) between the 2 groups. However, a higher reduction in the number of these exacerbations per year was seen with Trimbow in a sub-group of patients with persistent airflow limitation, representing almost two thirds of patients analysed. When looking at the results from the 2 studies together, Trimbow was found to have a beneficial effect on the rate of severe exacerbations.

What are the risks associated with Trimbow?

Side effects with Trimbow (which may affect up to 1 in 10 people) include dysphonia (changes in the sound of the voice), oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth. In asthma, side effects tend to occur in the first 3 months after start of treatment and then become less frequent.For the full list of side effects and restrictions with Trimbow, see the package leaflet.

Why is Trimbow authorised in the EU?

Trimbow has been shown to be effective at reducing the frequency of exacerbations and improving lung function of patients with COPD and asthma. No major safety concerns have been reported with Trimbow, with side effects being manageable and similar to other COPD and asthma medicines. The European Medicines Agency therefore decided that Trimbow'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 Trimbow?

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


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Trisenox


What is Trisenox and what is it used for?

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

How is Trisenox used?

Trisenox can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias. It is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The infusion should last one to two hours, but it may last longer if the patient has certain side effects.The recommended dose of Trisenox depends on the body weight of the patient. The treatment is divided into 2 phases: induction and consolidation.During the induction phase, Trisenox is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells). If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.During the consolidation phase, Trisenox is given once a day for five days, followed by a two-day break, repeated for four or five weeks. The number of times these cycles are repeated depends on whether patients have received previous treatment or not. For further information, see the package leaflet.

How does Trisenox work?

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

What benefits of Trisenox have been shown in studies?

Trisenox has been investigated in 159 newly diagnosed patients who had not yet received any treatment for APL. Trisenox was compared with an anthracycline (a type of cancer medicine), both taken in combination with ATRA, and the measure of effectiveness was the number of patients who did not experience any event (such as worsening of their disease or death) 2 years after diagnosis. 97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid. Forty-five of the patients in the studies were adults. Trisenox was not compared with any other medicine in either study. The main measure of effectiveness was the number of patients who had complete remission. This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered. Looking at the results of these two studies together, 87% of the patients had complete remission (45 out of 52). On average, it took 57 days for the patients to reach complete remission.

What are the risks associated with Trisenox?

The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes). For the full list of all side effects and restrictions with Trisenox, see the package leaflet.

Why is Trisenox approved?

The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.Trisenox was originally authorised under 'exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval. As the company had supplied the additional information requested, the 'exceptional circumstances' ended on 10 August 2010.

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

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


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Triumeq


What is Triumeq and what is it used for?

Triumeq is a medicine for treating infection with human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). It is used in adults, adolescents and children who weigh at least 14 kg.Triumeq contains three active substances: dolutegravir, abacavir and lamivudine.

How is Triumeq used?

Triumeq can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.Before starting treatment with Triumeq, all patients should have a test to find out if they have a gene called 'HLA-B (type 5701)'. Patients with this gene are at an increased risk of an allergic reaction to abacavir, so they should not take Triumeq.Triumeq is available as:• tablets containing 50 mg dolutegravir, 600 mg abacavir and 300 mg lamivudine for adults, adolescents and children weighing at least 25 kg. The recommended dose is one tablet a day.• dispersible tablets containing 5 mg dolutegravir, 60 mg abacavir and 30 mg lamivudine for children weighing at least 14 kg and less than 25 kg. The recommended dose depends on the weight of the patient.Triumeq can be taken with or without food.For more information about using Triumeq, see the package leaflet or contact your doctor or pharmacist.

How does Triumeq work?

One of the active substances in Triumeq, dolutegravir, is an integrase inhibitor. It blocks an enzyme called integrase that is needed by the virus to make new copies of itself in the body. The other twoactive substances, abacavir and lamivudine, are nucleoside reverse-transcriptase inhibitors (NRTIs). They both work by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to make more copies of itself in the cells it has infected and so spread in the body.Triumeq does not cure HIV infection but it reduces the amount of HIV in the body and keeps it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with AIDS.All three active substances in Triumeq are already available in the EU as single-component medicines: abacavir has been authorised as Ziagen since 1999, lamivudine as Epivir since 1996, and dolutegravir as Tivicay since 2014. The combination of abacavir and lamivudine has been authorised as Kivexa since 2004.

What benefits of Triumeq have been shown in studies?

The combination of dolutegravir, abacavir and lamivudine (as found in Triumeq) was evaluated in one main study involving 833 previously untreated patients. Data from this study had already been used in the authorisation of Tivicay.Patients were either given the Triumeq combination or a different three-drug combination (Atripla) that did not include an integrase inhibitor. After 48 weeks, 88% of the patients given Triumeq no longer had detectable levels of HIV (below 50 copies per ml of plasma [the liquid part of the blood]), compared with 81% of the patients who were given Atripla. Data from this study collected until week 96 showed that this effect was maintained over time.The company also looked at the way Triumeq was absorbed in the body in comparison with two separate tablets (dolutegravir and abacavir/lamivudine) containing the three medicines that make up Triumeq. Results from this study showed that Triumeq was absorbed in the body in the same way as the separate medicines.Studies were also carried out to show that recommended doses of tablets and dispersible tablets in children produced levels of active substances in the body that were similar to what is seen in adults.

What are the risks associated with Triumeq?

The most common side effects with Triumeq (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), diarrhoea and fatigue (tiredness). For the full list of side effects of Triumeq, see the package leaflet.Triumeq must not be used together with certain medicines such as fampridine (a multiple sclerosis medicine, also called dalfampridine), as this may increase the level of such medicines in the body, resulting in serious side effects. Serious hypersensitivity reactions (allergic reactions) requiring the patient to stop treatment permanently may occur with Triumeq, especially in people with the HLA-B (type 5701) gene. For the full list of restrictions with Triumeq, see the package leaflet.

Why is Triumeq authorised in the EU?

The European Medicines Agency decided that Triumeq's benefits are greater than its risks and it can be authorised for use in the EU. The Agency concluded that the medicine had demonstrated its effectiveness in previously untreated patients, and that similar benefits are expected in previously treated patients.The Agency also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene. The combined medicine reduces the number of tablets patients have to take, helping them to adhere to their treatment. In addition, the Agency considered the fact that Triumeq can be taken with or without food as an additional advantage compared with other similar medicines which have to be taken strictly either with food or on an empty stomach. Finally, Triumeq's safety profile was expected to be similar to the safety profile of the single components and comparable to that of other HIV treatments.

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

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


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Trixeo Aerosphere


What is Trixeo Aerosphere and what is it used for?

Trixeo Aerosphere is a medicine used to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD), a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.Trixeo Aerosphere is used for maintenance (regular) treatment in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist.Trixeo Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.

How is Trixeo Aerosphere used?

Trixeo Aerosphere can only be obtained with a prescription. It is available in a portable inhaler device. The recommended dose is two inhalations twice a day (two in the morning and two in the evening).Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional.For more information about using Trixeo Aerosphere, see the package leaflet or contact your doctor or pharmacist.

How does Trixeo Aerosphere work?

Trixeo Aerosphere contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. This means that it blocks muscarinic receptors in muscle cells in the airways. Because these receptors help control the contraction of muscles, glycopyrronium causes the muscles of the airways to relax, helping to keep the airways open.Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby keeping the airways clear and allowing the patient to breathe more easily.

What benefits of Trixeo Aerosphere have been shown in studies?

Two main studies in over 10,000 patients with moderate to very severe COPD have shown that Trixeo Aerosphere is effective at improving patients' FEV1 (the maximum volume of air they can breathe out in one second) and at reducing the number of exacerbations (flare-ups) of the disease.In the first study, patients treated with Trixeo Aerosphere for 24 weeks had FEV1 increases of around 147 ml, compared with 125 ml for patients treated with glycopyrronium/formoterol, and 73 ml and 88 ml for patients treated with two different inhalers containing budesonide/formoterol.The second study, which lasted one year, showed that patients treated with Trixeo Aerosphere had fewer COPD exacerbations (1.08 per year) than patients treated with with glycopyrronium/formoterol (1.42) or budesonide/formoterol (1.24).

What are the risks associated with Trixeo Aerosphere?

The most common side effects with Trixeo Aerosphere (which may affect up to 1 in 10 people) are pneumonia (lung infection), headache and urinary tract infection.For the full list of side effects and restrictions of Trixeo Aerosphere, see the package leaflet.

Why is Trixeo Aerosphere authorised in the EU?

Trixeo Aerosphere improved lung function in patients with moderate to severe COPD, and reduced disease exacerbations. The safety profile of Trixeo Aerosphere is considered similar to that of medicines containing combinations of a corticosteroid, beta-2 agonist and antimuscarinic. The European Medicines Agency therefore decided that Trixeo Aerosphere'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 Trixeo Aerosphere?

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


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Trizivir


What is Trizivir and what is it used for?

Trizivir is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS). It is used to replace treatment with the three active substances (abacavir, lamivudine and zidovudine) taken separately at doses similar to those in Trizivir. Patients should have been taking the three active substances separately for at least 6 weeks before switching to Trizivir.Trizivir contains three active substances: abacavir, lamivudine and zidovudine.

How is Trizivir used?

Trizivir can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing HIV infection.Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called 'HLA-B (type 5701)'. Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Trizivir.Trizivir is available as tablets (300 mg abacavir/150 mg lamivudine/300 mg zidovudine). The recommended dose is one tablet twice a day. If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately. For more information about using Trizivir, see the package leaflet or contact your doctor or pharmacist.

How does Trizivir work?

All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs). They work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to make more copies of itself in the cells it has infected and so spread in the body. Trizivir does not cure HIV infection but it reduces the amount ofHIV in the blood and keeps it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with AIDS.All three active substances have been available in the European Union (EU) for a number of years: abacavir has been authorised as Ziagen since 1999, lamivudine has been authorised as Epivir since 1996, and zidovudine has been available in the EU since the mid-1980s.

What benefits of Trizivir have been shown in studies?

No specific clinical studies have been carried out to assess the safety and effectiveness of the combined tablet. The company presented the results of studies with abacavir, lamivudine and zidovudine taken together, which were carried out during the development of Ziagen. In these studies, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low.The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets. The combination tablet was absorbed in the body in the same way as the separate tablets.

What are the risks associated with Trizivir?

The most common effects with Trizivir (which may affect more than 1 in 10 people) are headache and nausea (feeling sick). For the full list of side effects of Trizivir, see the package leaflet.Hypersensitivity reactions (allergic reactions) occur in patients taking Trizivir, usually within the first 6 weeks of treatment, and can be life-threatening. The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene. Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal (belly) pain, headache, blood tests showing signs of liver damage, muscle pain, dyspnoea (difficulty breathing), cough, lethargy (lack of energy) and feeling unwell. Treatment with Trizivir should be stopped promptly if the patient has a hypersensitivity reaction. For more information, see the package leaflet.Trizivir must not be used in patients who have kidney failure. Because it contains zidovudine, Trizivir must not be used by patients with low neutrophil counts (low levels of a type of white blood cell) or anaemia (low red blood cell counts). For the full list of restrictions, see the package leaflet.

Why is Trizivir authorised in the EU?

The European Medicines Agency noted that reducing the number of tablets that patients need to take may help patients stick to their treatment. The Agency therefore decided that Trizivir'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 Trizivir?

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


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Trodelvy


What is Trodelvy and what is it used for?

Trodelvy is a cancer medicine used to treat adults with a type of breast cancer known as triplenegative breast cancer. In triple-negative breast cancer, the cancer cells do not have receptors (targets) for certain hormones on their surface and do not make abnormally high levels of a protein called HER2 (HER2-negative). In these patients, the medicine is used when it is not possible to remove the cancer with surgery because the cancer has spread to areas outside the breast (locally advanced) or to other parts of the body (metastatic). It is used in patients who have had two or more prior systemic (whole body) treatments, including at least one of them for advanced disease.Trodelvy is also used for treating breast cancer when the cancer cells have receptors for certain hormones on their surface (HR-positive) and are HER2-negative. It is used in patients who have had endocrine-based therapy (hormone treatment) as well as two or more prior systemic treatments when their cancer cannot be removed by surgery or is metastatic.Trodelvy contains the active substance sacituzumab govitecan.

How is Trodelvy used?

The medicine can only be obtained with a prescription. It should be prescribed and given by a healthcare professional who has experience in the use of cancer medicines. It should be given in asetting where resuscitation equipment is available if patients develop severe allergic reactions.Trodelvy is given by infusion (drip) into a vein on day 1 and day 8 of a repeating 3-week cycle. Treatment may be continued for as long as it remains effective and the patient does not have unacceptable side effects.All patients are monitored for any reactions during the infusion and for at least 30 minutes afterwards. Infusion-related reactions can be severe and, to reduce their risk, patients should be given other medicines before treatment with Trodelvy. If the patient develops infusion-related reactions, the doctor may slow down or interrupt the infusion.For more information about using Trodelvy, see the package leaflet or contact your doctor or pharmacist.

How does Trodelvy work?

The active substance in Trodelvy, sacituzumab govitecan, consists of two active components: a monoclonal antibody (a type of protein) that has been linked to a small molecule, SN-38. The monoclonal antibody has been designed to recognise and attach to Trop-2, a protein found on many breast cancer cells.Once attached, the medicine is taken up by the cell where SN-38 becomes active. SN-38 blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die.

What benefits of Trodelvy have been shown in studies?

Trodelvy has been compared with standard treatment in one main study involving 529 patients with metastatic or locally advanced triple-negative breast cancer who received two or more prior systemic(whole body) treatments, including at least one of them for advanced disease. Patients who took Trodelvy lived for an average of 4.8 months without their disease worsening, compared with 1.7 months for the patients who took standard treatment. Patients on Trodelvy lived for an average of11.8 months compared with 6.9 months for patients on standard treatment.Another main study compared Trodelvy to one of four commonly used chemotherapy treatments as chosen by the doctor in 543 patients with HR-positive HER2-negative metastatic breast cancer who had received endocrine-based therapy and at least two systemic chemotherapy treatments before. Patients who received Trodelvy lived for an average of 5.5 months before their disease got worse, compared with 4.0 months for patients who were given another treatment. Patients on Trodelvy lived for an average of 14.4 months compared with 11.2 months for the other group of patients.

What are the risks associated with Trodelvy?

For the full list of side effects and restrictions with Trodelvy, see the package leaflet.The most common side effects with Trodelvy (which may affect more than 1 in 5 people) include neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), nausea, diarrhoea, tiredness, alopecia (hair loss), anaemia (low levels of haemoglobin which can cause tiredness and pale skin), constipation, vomiting, decreased appetite, dyspnoea (difficulty breathing) and abdominal (belly) pain.The most common serious side effects include febrile neutropenia (low white blood cell counts with fever due to infection), diarrhoea, neutropenia and pneumonia (infection of the lungs).

Why is Trodelvy authorised in the EU?

The European Medicines Agency decided that Trodelvy's benefits are greater than its risks and it can be authorised for use in the EU.Trodelvy has shown meaningful improvements in overall survival in patients with metastatic triplenegative breast cancer who received two or more prior systemic treatments, including at least one of them for advanced disease. Similar improvements were seen in how long patients lived without their disease worsening. Trodelvy has also shown meaningful improvements in heavily pre-treated patients with HR-positive HER2-negative metastatic breast cancer. Most patients in the main studies had metastatic cancer, but the Agency considered that similar benefits could be expected in patients with locally advanced cancer that cannot be removed by surgery.In terms of safety, although Trodelvy has important side effects compared with standard treatments, such as severe neutropenia and diarrhoea, they are considered manageable with medications and dose modifications.

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

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


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Trulicity


What is Trulicity and what is it used for?

Trulicity is a medicine used in adults and children from 10 years of age with type 2 diabetes. It is used in addition to appropriate diet and exercise.Trulicity is used:- on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;- as an 'add-on' to other diabetes medicines.Trulicity contains the active substance dulaglutide.

How is Trulicity used?

Trulicity can only be obtained with a prescription. It is available as prefilled pens containing a solution to be injected under the skin in the abdomen (belly), in the thigh or in the upper arm.For more information about using Trulicity, see the package leaflet or contact your doctor or pharmacist.

How does Trulicity work?

The active substance in Trulicity, dulaglutide, is a 'GLP-1 receptor agonist'. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps to control blood glucose levels and symptoms of type 2 diabetes.

What benefits of Trulicity have been shown in studies?

In adults, the effectiveness of Trulicity has been studied in 5 main studies involving over 4,500 patients with type 2 diabetes. In these studies, Trulicity was compared with placebo (a dummy treatment) or with other diabetes medicines when used alone or as an add-on to various combination treatments. Information from a supportive study sent with the application was also considered.The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached to it. HbA1c gives anindication of how well blood glucose is controlled. The patients' HbA1c at baseline ranged from 7.6 to8.5% and patients were treated for at least 52 weeks.Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and it was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose. This was considered clinically meaningful and there was evidence that HbA1c levels remained low during longterm treatment. About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.A further study in 9,901 adults with type 2 diabetes found Trulicity effective at reducing major harmful effects on the heart and the circulatory system. Stroke, heart attack or death from heart of circulatory problems occurred in 12.0% of patients receiving Trulicity over about 5 years compared with 13.4% of patients receiving placebo.The benefits of Trulicity were also investigated in one main study involving 154 children from 10 years of age with type 2 diabetes. After 26 weeks of treatment, patients on Trulicity had a reduction in HbA1c levels of 0.7 percentage points, versus an increase of 0.6 percentage points for patients on placebo. This difference between Trulicity and placebo was considered clinically meaningful.

What are the risks associated with Trulicity?

The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea. For the full list of side effects and restrictions of Trulicity, see the package leaflet.

Why is Trulicity authorised in the EU?

The European Medicines Agency decided that Trulicity's benefits are greater than its risks and it can be authorised for use in the EU. The medicine was effective for treating type 2 diabetes: it improved control of blood sugar levels in adults and children from 10 years of age and was shown to reduce harmful effects on the heart and blood circulation in adults. In addition, Trulicity has the advantage that it can be given once a week. The medicine's side effects are considered manageable.

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

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


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Trumenba


What is Trumenba and what is it used for?

Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spinal cord) and septicaemia (blood infection).

How is Trumenba used?

Trumenba can only be obtained with a prescription and should be used according to official recommendations. It is available in a pre-filled syringe and is given by injection into a muscle, preferably in the shoulder. Initial treatment may either involve 2 injections at least 6 months apart, or 2 injections at least 1 month apart followed by a third injection at least 4 months later. In patients at greater risk of invasive meningococcal disease, an additional booster dose may be considered later on.

How does Trumenba work?

Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the parts of thebacterium contained in the vaccine as 'foreign' and makes antibodies against them. When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.Trumenba contains two components, proteins that are found in the outer coats of Neisseria meningitidis group B bacteria. These proteins are fixed onto a compound containing aluminium (adsorbed), which helps to stabilise them, allowing the immune system to respond to them.

What benefits of Trumenba have been shown in studies?

Trumenba has been shown to trigger the production of protective levels of antibodies against Neisseria meningitidis group B in two main studies. The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection. The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested. In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants. Antibody responses were also seen against the 10 secondary strains and confirmed the responses seen with the 4 main strains.Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.

What are the risks associated with Trumenba?

The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea (feeling sick), and muscle or joint pain.For the full list of all side effects and restrictions with Trumenba, see the package leaflet.

Why is Trumenba approved?

The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule. As the protection provided seemed to decline over time, a booster dose should be considered in recipients who were thought to be at continued risk of invasive meningococcal disease. Although side effects were common, they appeared to be within acceptable limits. Further planned or ongoing studies are expected to provide more information on Trumenba's effectiveness.The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that based on available data Trumenba's benefits are greater than its risks and recommended that it be approved for use in the EU.

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

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


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Truvada


What is Truvada and what is it used for?

Truvada is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). In addition it may be used from the age of 12 in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.Truvada is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP). It should be used in combination with safer sex practices, such as use of condoms.Truvada contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).

How is Truvada used?

Truvada can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the management of HIV infection.Truvada is available as tablets. The recommended dose for treating or preventing HIV-1 infection is one tablet once a day, preferably taken with food. If patients with HIV-1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.For more information, see the package leaflet.

How does Truvada work?

Truvada contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a 'prodrug' of tenofovir. This means that it is converted into tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.Send aFor the treatment of HIV-1 infection, Truvada, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level. Truvada does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.For pre-exposure prophylaxis of HIV-1 infection, it is expected that Truvada in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.Both active substances have been authorised in the European Union (EU) since the early 2000s:emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in 2002.

What benefits of Truvada have been shown in studies?

Two main studies have examined the effects of Truvada's active substances, emtricitabine and tenofovir disoproxil, in adults infected with HIV-1 who had not been treated before. The main measure of effectiveness was the proportion of patients whose HIV-1 level in the blood (viral load) had fallen below a defined level. Truvada's active substances, taken in combination with other antiviral medicines, reduced viral load in the majority of patients and were more effective than the comparator medicines.The first study compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral medicines). Both combinations were taken with efavirenz (another antiviral medicine) by patients with HIV-1 infection. Of the patients taking the active substances of Truvada, 80% (194 out of 244) achieved and maintained viral load below 50 HIV1 copies/ml by 48 weeks, compared with 70% of the patients taking the comparator medicines (171 out of 243).The second study examined the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral medicines) in 196 patients with HIV-1 infection. Around two-thirds of the patients achieved and maintained viral load below 50 copies/ml after 48 weeks.The effectiveness of Truvada in adolescents was supported by studies showing that emtricitabine or tenofovir disoproxil reduced viral load when given with other antivirals to HIV-infected patients aged from 12 to 18 years, as well as evidence that the active ingredients are distributed similarly in the bodies of adolescents to those of adults and so would be expected to act in the same way.Two main studies have evaluated the addition of Truvada to standard preventative measures for preexposure prophylaxis. In both studies Truvada was compared with placebo (a dummy treatment) in adults at high risk of sexually transmitted HIV-1 infection. The main measure of effectiveness was the number of adults who tested positive for HIV-1 infection. Truvada was more effective than placebo for preventing HIV-1 infection. The level of protection depended on how well individuals stuck to taking their medicine.In the first study involving over 2,400 men who have sex with men, 3.9% (48 out of 1,224) individuals taking Truvada tested positive for HIV-1 infection compared with 6.8% (83 out of 1,217) individuals taking placebo.The second study involved over 4,700 heterosexual couples, each with one partner who did not haveHIV-1 infection and the other who had the infection. Of the individuals taking Truvada, 0.8% (13 out of 1,576) tested positive for HIV-1 infection over 1 year compared with 3.3% (52 out of 1,578) of those taking placebo.

What are the risks associated with Truvada?

The most common side effects in adults treated with Truvada are diarrhoea and nausea (feeling sick). When the active substances emtricitabine or tenofovir are given separately, the most common side effects (seen in more than 1 patient in 10) also include hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, vomiting, rash, weakness and raised blood levels of creatine kinase (an enzyme found in muscles). In children, skin discoloration and anaemia (low red blood cell counts) are also common side effects. For the full list of all side effects reported with Truvada, see the package leaflet.Truvada can be used for pre-exposure prophylaxis only in individuals who have been tested to be free of HIV infection. Individuals taking Truvada to prevent HIV-1 infection should be tested at least every 3 months to make sure that they are free of HIV-1. For the full list of restrictions, see the package leaflet.

Why is Truvada authorised in the EU?

The European Medicines Agency noted that the benefit of Truvada for treating HIV-1 infection has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.The Agency also considered that the benefit of Truvada has been shown for pre-exposure prophylaxis but the level of protection depends on how well individuals stick to the recommended dose schedule. There is a risk that pre-exposure prophylaxis may encourage risky behaviour but one of the main studies found that participation in the study reduced risky behaviour.The Agency concluded that Truvada'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 Truvada?

The company that markets Truvada will provide an information pack to doctors which covers the risk of reduced kidney function with Truvada in adults and children, and information about use in adults for pre-exposure prophylaxis. Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving Truvada for pre-exposure prophylaxis.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truvada have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Truvada is continuously monitored. Side effects reported with Truvada are carefully evaluated and any necessary action taken to protect patients.


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Truvelog Mix 30


What is Truvelog Mix 30 and what is it used for?

Truvelog Mix 30 is an insulin medicine used to treat patients from 10 years of age who have diabetes and need insulin to keep their blood glucose (sugar) level controlled.Truvelog Mix 30 is a 'biosimilar medicine'. This means that Truvelog Mix 30 is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Truvelog Mix 30 is NovoMix 30. For more information on biosimilar medicines, see here.Truvelog Mix 30 contains the active substance insulin aspart combined with protamine to make it longer acting.

How is Truvelog Mix 30 used?

Truvelog Mix 30 can only be obtained with a prescription and is given as an injection under the skin in the upper arm, thigh, buttock or belly, usually shortly before a meal or, if more appropriate, soon after a meal. The dose is worked out for each patient and depends on the patient's weight and blood glucose level.In type 2 diabetes, Truvelog Mix 30 can be given on its own or together with other diabetes medicines.A healthcare professional should explain to the patient how to use the medicine properly.For more information about using Truvelog Mix 30, see the package leaflet or contact your doctor or pharmacist.

How does Truvelog Mix 30 work?

In diabetes, patients have high levels of blood glucose because either the body does not produce enough insulin or the body is unable to use insulin effectively. Truvelog Mix 30 is a replacement insulin that helps control blood glucose levels, thereby alleviating symptoms of diabetes and reducing the risk of complications.The insulin aspart in Truvelog Mix 30 is a form of insulin which is absorbed more quickly by the body than regular insulin and can therefore start working sooner after it is injected. In Truvelog Mix 30, 30%of the active substance is in this rapid acting form, and 70% in a longer acting form combined with protamine (insulin aspart protamine), which is absorbed more slowly and so works for longer.

What benefits of Truvelog Mix 30 have been shown in studies?

Laboratory studies comparing Truvelog Mix 30 with NovoMix 30 have shown that the active substance in Truvelog Mix 30 is highly similar to that in NovoMix 30 in terms of structure, purity and biological activity. Studies have also shown that giving Truvelog Mix 30 produces similar levels of the active substance in the body to giving NovoMix 30.Because Truvelog Mix 30 is a biosimilar medicine, the studies on effectiveness and safety of insulin aspart carried out with NovoMix 30 do not all need to be repeated for Truvelog Mix 30.

What are the risks associated with Truvelog Mix 30?

The safety of Truvelog Mix 30 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 NovoMix 30.The most common side effects with Truvelog Mix 30 (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels) and the medicine must not be given to people whose blood glucose level is already low.For the full list of side effects and restrictions with Truvelog Mix 30, see the package leaflet.

Why is Truvelog Mix 30 authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Truvelog Mix 30 has a highly similar structure, purity and biological activity to NovoMix 30 and is distributed in the body in the same way.All these data were considered sufficient to conclude that Truvelog Mix 30 will behave in the same way as NovoMix 30 in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for NovoMix 30, the benefits of Truvelog Mix 30 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 Truvelog Mix 30?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truvelog Mix 30 have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Truvelog Mix 30 are continuously monitored. Suspected side effects reported with Truvelog Mix 30 are carefully evaluated and any necessary action taken to protect patients.


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Truxima


What is Truxima and what is it used for?

Truxima is a medicine used to treat the following blood cancers and inflammatory conditions:• follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer)• chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells)• severe rheumatoid arthritis (an inflammatory condition of the joints)• granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis(MPA), which are inflammatory conditions of the blood vessels• moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (moist body surfaces, such as the lining of the mouth). 'Autoimmune' means that the disease is caused by the immune system (the body's natural defences) attacking the body's own cells.Depending on the condition it is used to treat, Truxima may be given on its own, or with chemotherapy(other cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid). Truxima contains the active substance rituximab.Truxima is a 'biosimilar medicine'. This means that Truxima is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Truxima is MabThera. For more information on biosimilar medicines, see here.

How is Truxima used?

Truxima can only be obtained with a prescription. It is given by infusion (drip) into a vein. Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an antipyretic (a medicine to prevent fever). Depending on the condition being treated, patients may receive other medicines as well. In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.For more information about using Truxima, see the package leaflet or contact your doctor or pharmacist.

How does Truxima work?

The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to attach to a protein called CD20 present on the surface of B cells (types of white blood cells). When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL (where B cells have become cancerous) and in rheumatoid arthritis (where B cells are involved in joint inflammation). In pemphigus vulgaris, GPA and MPA, destroying the B cells reduces the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.

What benefits of Truxima have been shown in studies?

Extensive laboratory studies comparing Truxima with MabThera have shown that rituximab in Truxima is highly similar to rituximab in MabThera in terms of structure, purity and biological activity.Truxima has been compared with MabThera given into a vein in a study involving 372 patients with active rheumatoid arthritis. The study showed that Truxima and MabThera led to similar levels of rituximab in the blood. In addition, the two medicines had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Truxima and 73% (43 of 59 patients) with MabThera. Supportive studies in patients with rheumatoid arthritis and in patients with advanced follicular lymphoma also indicated that the medicines produced similar responses.Because Truxima is a biosimilar medicine, the studies on effectiveness and safety carried out for MabThera do not all need to be repeated for Truxima.

What are the risks associated with Truxima?

The safety of Truxima has been evaluated and, on the basis of all the studies, its side effects are considered comparable to those of the reference medicine MabThera.The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in the majority of patients after the first infusion. The risk of such reactions decreases with subsequent infusions. The most common serious side effects are infusion reactions, infections (which may affect more than half of all patients) and heart-related problems. Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare severe infection known as progressive multifocal leukoencephalopathy (PML). For the full list of side effects of Truxima, see the package leaflet.Truxima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients. It must also not be used in patients with a severe infection or a severely weakened immune system. Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Truxima if they have severe heart problems.

Why is Truxima authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Truxima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way. In addition, a study comparing Truxima to MabThera in rheumatoid arthritis adult patients showed that both medicines are similarly effective.All these data were considered sufficient to conclude that Truxima will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for MabThera, the benefits of Truxima 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 Truxima?

The company marketing Truxima will provide doctors and patients using the medicine for non-cancer conditions with educational material on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML. Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.Doctors prescribing Truxima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truxima have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Truxima are continuously monitored. Side effects reported with Truxima are carefully evaluated and any necessary action taken to protect patients.


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Trydonis


What is Trydonis and what is it used for?

Trydonis is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.Trydonis is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist. Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs..This medicine is the same as Trimbow, which is already authorised in the EU. The company that makes Trimbow has agreed that its scientific data can be used for Trydonis ('informed consent').Trydonis contains the active substances beclometasone, formoterol and glycopyrronium bromide.

How is Trydonis used?

Trydonis is available as a liquid in a portable inhaler device. The recommended dose is two inhalations twice a day.Patients should be shown how to use the inhaler correctly by a doctor or another healthcare professional, who should also regularly check that the patient's inhalation technique is correct.The medicine can only be obtained with a prescription. For more information about using Trydonis, see the package leaflet or contact your doctor or pharmacist.

How does Trydonis work?

The three active substances in Trydonis work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.Beclometasone belongs to anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system. This leads to a reduction in the release of substances involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. It opens the airways by blocking muscarinic receptors in muscle cells in the lungs. Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.

What benefits of Trydonis have been shown in studies?

Trydonis has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.In the first study lasting a year, after 26 weeks of treatment, Trydonis improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose. By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Trydonis (beclometasone plus formoterol).In the second study lasting a year, patients treated with Trydonis had 20% fewer exacerbations (flareups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist). In this study, Trydonis was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.In the third study lasting a year, patients treated with Trydonis had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.

What are the risks associated with Trydonis?

Side effects with Trydonis include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.For the full list of side effects and restrictions with Trydonis, see the package leaflet.

Why is Trydonis authorised in the EU?

Trydonis is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD. No major safety concerns have been reported with Trydonis, with side effects being manageable and similar to other COPD medicines. The European Medicines Agency therefore decided that Trydonis'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 Trydonis?

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


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Tukysa


What is Tukysa and what is it used for?

Tukysa is a cancer medicine that is used to treat breast cancer that is locally advanced or metastatic (has spread to other parts of the body) and when it is HER2-positive. This means the cancer cells produce a protein on their surface, HER2, which stimulates the growth of the cancer.Tukysa is used with two other medicines, capecitabine and trastuzumab, and is used after at least 2 other treatments for HER2-positive cancer have already been tried.The active substance in Tukysa is tucatinib.

How is Tukysa used?

Tukysa can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in giving cancer treatments. It is given by mouth in a recommended dose of 300 mg twice a day. Patients are also treated with capecitabine and trastuzumab on certain days of a 21-day cycle.Treatment can continue as long as the cancer does not get worse and side effects are bearable. The doctor may recommend a reduced dose of Tukysa if certain side effects occur, or may stop treatment temporarily or permanently.For more information about using Tukysa, see the package leaflet or contact your doctor.

How does Tukysa work?

The active substance in Tukysa, tucatinib, is a type of cancer medicine called a tyrosine kinase inhibitor. It attaches to the HER2 protein on the cancer cells, and so blocks its action. Because HER2 helps cancer cells to grow and divide, blocking it helps to stop these cells growing and causes them to die, controlling the growth of the cancer.

What benefits of Tukysa have been shown in studies?

Tukysa has been shown to improve the length of time that patients with advanced or metastatic HER2positive breast cancer lived without their disease getting worse. In an ongoing main study involving612 such patients whose disease had got worse after previous treatments or in whom other treatments were unsuitable, Tukysa was compared with placebo (a dummy treatment) when added to two other cancer medicines, trastuzumab and capecitabine.When the results were analysed, the average length of time that patients lived without their disease getting worse was 7.8 months with Tukysa and 5.6 months with placebo. Overall, around 41% of patients given Tukysa and 23% given placebo showed some response to treatment and the two groups lived on average about 22 months and 17 months respectively. Responses to Tukysa were comparable in the subgroup of patients whose cancer had spread to the brain.

What are the risks associated with Tukysa?

The most common side effects with Tukysa (which may affect more than 1 in 10 people) are nose bleeds, diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the mouth), rash, arthralgia (joint pain), increases in the blood levels of liver enzymes ALT and AST (a sign of potential liver problems) and in bilirubin, and weight loss. The most common serious side effects with Tukysa (which may affect more than 1 in 20 people) are diarrhoea and increased ALT and AST; nausea and vomiting may also be serious.For the full list of side effects and restrictions with Tukysa, see the package leaflet.

Why is Tukysa authorised in the EU?

The European Medicines Agency noted that the evidence showed an improvement in survival with Tukysa in a group of patients who had few alternative options. The company would need to provide final results of the main study to clarify the exact extent of the benefits. The reported side effects were considered manageable, and mostly related to effects on the gut. The Agency therefore decided that Tukysa'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 Tukysa?

The company that markets Tukysa will provide final results from the main study showing the length of time patients live overall as well as without their disease getting worse.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tukysa have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tukysa are continuously monitored. Side effects reported with Tukysa are carefully evaluated and any necessary action taken to protect patients.


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Twinrix Adult


What is Twinrix Adult?

Twinrix Adult is a vaccine, which is available as a suspension for injection. It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances. It is available in a 1 ml vial and in a 1 ml prefilled syringe.

What is Twinrix Adult used for?

Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver). It is used in adults and adolescents from 16 years of age who are not already immune to these two diseases and who are at risk of contracting both of them. The medicine can only be obtained with a prescription.

How is Twinrix Adult used?

The recommended vaccination schedule for Twinrix Adult is three doses, with a gap of one month between the first two doses and a gap of five months between the second and third. The vaccine is injected into the muscle of the upper arm.In exceptional cases, the three injections can be given over three weeks for adults needing rapid protection before travelling. In these cases, a fourth injection is recommended 12 months after the first dose.It is recommended that individuals who receive the first dose should complete all doses of Twinrix Adult. A booster dose of Twinrix Adult, or of a separate hepatitis A or B vaccine may be given, according to official recommendations.

How does Twinrix Adult work?

Twinrix Adult is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the 'surface antigen' (proteins from the surface) of the hepatitis B virus. When a person is given the vaccine, the immune system recognises the viruses and surface antigens as 'foreign' and makes antibodies against them. If exposed to the viruses in the future, the immune system will be able to make antibodies more quickly. The antibodies will help to protect against diseases caused by these viruses.The vaccine is 'adsorbed'. This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response. The surface antigens of the hepatitis B virus are producedby a method known as 'recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.

How has Twinrix Adult been studied?

Twinrix Adult has been studied in three main studies involving 843 healthy people aged between 18 and 60 years, most of whom were under 40 years of age. Each person received Twinrix Adult doses at months 0, 1 and 6. The main measure of effectiveness was the proportion of the people who had developed antibodies against hepatitis A and B.Further studies looked at the persistence of antibodies after vaccination in adults and adolescents, and at the schedule for vaccinating adults over three weeks when rapid protection is required.

What benefit has Twinrix Adult shown during the studies?

The studies showed that for hepatitis A, antibodies were detected in 94% of adults after the first dose, 99.5% after the second dose and 100% after the third dose. For hepatitis B, antibodies were detected in 71% of adults after the first dose, 97% after the second dose and 99.7% after the third dose.The additional studies showed that the presence of antibodies was maintained for up to five years. The three-week vaccination schedule also led to the production of antibodies in around 83% of patients, rising to around 89% after the booster dose at month 12.

What is the risk associated with Twinrix Adult?

The most common side effects with Twinrix Adult (seen in more than 1 in 10 doses of the vaccine) are headache, pain and redness at the injection site, and fatigue (tiredness). For the full list of all side effects reported with Twinrix Adult, see the Package Leaflet.Twinrix Adult should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines. Twinrix Adult should be postponed in patients with a severe sudden fever. It should never be injected into a vein.

Why has Twinrix Adult been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult's benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection. The Committee recommended that Twinrix Adult be given marketing authorisation.


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Twinrix Paediatric


What is Twinrix Paediatric?

Twinrix Paediatric is a vaccine, which is available as a suspension for injection. It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances. It is available in a 0.5 ml vial and in a 0.5 ml prefilled syringe.

What is Twinrix Paediatric used for?

Twinrix Paediatric is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver). It is used in infants, children and adolescents aged between one and 15 years who are not already immune to these two diseases and who are at risk of contracting both of them. The medicine can only be obtained with a prescription.

How is Twinrix Paediatric used?

The recommended vaccination schedule for Twinrix Paediatric is three doses with a gap of one month between the first two doses and a gap of five months between the second and third. It should be given by injection into the muscle of the upper arm or the thigh.It is recommended that individuals who receive the first dose should complete all three doses of Twinrix Paediatric.A booster dose of Twinrix Paediatric, or of a separate hepatitis A or B vaccine may be given, according to official recommendations.

How does Twinrix Paediatric work?

Twinrix Paediatric is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Twinrix Paediatric contains small amounts of inactivated hepatitis A viruses and the 'surface antigen' (proteins from the surface) of the hepatitis B virus. When a person is given the vaccine, the immune system recognises the viruses and surface antigens as 'foreign' and makes antibodies against them. In the future, the immune system will be able to make antibodies more quickly when it is exposed to the viruses. The antibodies will help to protect against diseases caused by these viruses.The vaccine is 'adsorbed'. This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response. The surface antigens of the hepatitis B virus are produced by a method known as 'recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.Twinrix Paediatric is identical to the vaccine Twinrix Adult, which has been available in the European Union (EU) since 1996. The only difference between the two vaccines is the amount of vaccine in each vial or syringe. The active substances in Twinrix Paediatric and Twinrix Adult have been available in the EU for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.

How has Twinrix Paediatric been studied?

Because Twinrix Paediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Twinrix Paediatric.Two studies were carried out in a total of 180 children and adolescents, all of whom received Twinrix Paediatric. The main measure of effectiveness was the proportion of the children who had developed protective levels of antibodies to hepatitis A and hepatitis B.Further studies looked at the persistence of antibody levels after vaccination.

What benefit has Twinrix Paediatric shown during the studies?

The studies showed that Twinrix Paediatric produced an immune response that was at least as good as that seen during studies of Twinrix Adult. All children had satisfactory antibody levels to hepatitis A by two months, and almost 100% had protective levels of antibodies to hepatitis B by six months (just before the third vaccine dose). Levels of antibodies to both hepatitis A and B increased after the third dose of the vaccine.The additional studies showed that the presence of antibodies was maintained for at least four years.

What is the risk associated with Twinrix Paediatric?

The most common side effect with Twinrix Paediatric (seen in more than 1 in 10 doses of the vaccine) is pain and redness at the injection site. For the full list of all side effects reported with Twinrix Paediatric, see the Package Leaflet.Twinrix Paediatric should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines. Twinrix Paediatric should be postponed in patients with a severe sudden fever. It should never be injected into a vein.

Why has Twinrix Paediatric been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric's benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection. The Committee recommended that Twinrix Paediatric be given marketing authorisation.


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Twynsta


What is Twynsta?

Twynsta is a medicine that contains two active substances, telmisartan and amlodipine. It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).

What is Twynsta used for?

Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over). 'Essential' means that the hypertension has no obvious cause.Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone. Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.The medicine can only be obtained with a prescription.

How is Twynsta used?

Twynsta is taken by mouth as one tablet once a day and is used for long-term treatment. The maximum dose is one tablet of the highest strength (80/10 mg) once a day.For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Twynsta. When appropriate, direct switch to Twynsta may be considered.For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.

How does Twynsta work?

Twynsta contains two active substances, telmisartan and amlodipine. Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.Telmisartan is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.

How has Twynsta been studied?

Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment). In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Twynsta or continued to take amlodipine at the same or a higher dose. The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.Studies were also carried to show that Twynsta tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.

What benefit has Twynsta shown during the studies?

In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.

What is the risk associated with Twynsta?

The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet). For the full list of all side effects reported with Twynsta, see the package leaflet.Twynsta must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the 'dihydropyridine derivatives' class or to any of the other ingredients. It must not be used in women who are more than three months pregnant. Twynsta must not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack). Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.

Why has Twynsta been approved?

The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta. In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone. The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorisation.


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Tybost


What is Tybost and what is it used for?

Tybost is a medicine for treating adults and adolescents from 12 years of age (and over a certain weight) who are infected with HIV-1, a virus that causes acquired immune deficiency syndrome (AIDS).Tybost does not treat HIV directly but is given to boost the effects of atazanavir or darunavir, which are used with other standard medicines to treat HIV-1.It contains the active substance cobicistat.

How is Tybost used?

Tybost is available as tablets (150 mg). The recommended dose is one tablet per day, taken with food. Tybost is given together with 300 mg atazanavir once per day (in patients weighing at least 35 kg) or with 800 mg darunavir once per day (in patients weighing at least 40 kg).Tybost can only be obtained with a prescription. Treatment should be started by a doctor who is experienced in managing HIV infection. For more information about using Tybost, see the package leaflet or contact your doctor or pharmacist.

How does Tybost work?

The active substance in Tybost, cobicistat, blocks the action of a group of liver enzymes called CYP3A, which are involved in breaking down medicines in the body. By blocking CYP3A, Tybost slows down the rate at which atazanavir and darunavir are broken down, allowing them to work for longer.Tybost is taken with atazanavir or darunavir, both of which are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of the HIV-1 virus. When the enzyme is blocked, the virus cannot reproduce normally, which slows down the spread of infection.Treatment with Tybost and atazanavir or darunavir does not cure HIV-1 infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS, when combined with other standard HIV-1 medicines.

What benefits of Tybost have been shown in studies?

A main study in patients infected with HIV-1 showed that Tybost was as effective as another booster medicine, ritonavir.In this study, both medicines were used to boost the effects of atazanavir, in combination with another standard HIV-1 medicine containing emtricitabine and tenofovir. After 48 weeks, around 85% of patients given Tybost had very low levels of HIV-1 (< 50 RNA copies/ml), compared with around 87% of patients given ritonavir.Further data indicated that Tybost was effective as a booster medicine with atazanavir or darunavir in adolescents between 12 and 17 years of age.

What are the risks associated with Tybost?

The most common side effects with Tybost (which may affect more than 1 in 10 people) when given with atazanavir are ocular icterus (yellowing of the whites of the eyes), nausea (feeling sick) and jaundice (yellowing of the skin and eyes). For the full list of side effects of Tybost, see the package leaflet.Tybost must not be taken together with a number of other medicines that affect the way Tybost is broken down or whose action is affected by Tybost. For the full list of restrictions, see the package leaflet.

Why is Tybost authorised in the EU?

Studies showed that Tybost was as effective as ritonavir as a booster for atazanavir, and a similar effect is expected for darunavir based on data on the impact of Tybost on the darunavir levels in the body. Furthermore, there were no safety concerns preventing Tybost from being used together with atazanavir or darunavir.The European Medicines Agency therefore decided that Tybost'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 Tybost?

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


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Tyenne


What is Tyenne and what is it used for?

Tyenne is a medicine used to treat:• adults with severe rheumatoid arthritis that is getting worse, who have not been previously treated with a medicine called methotrexate;• adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well enough or were not tolerated;• children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (anti-inflammatory medicines called NSAIDs and corticosteroids medicines by mouth or injection) have not worked well enough;• children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.Tyenne is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.Tyenne is also used to treat:• adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen;• adults and children from 2 years of age with severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure). CRS is a side effect of certain cancer treatments and Tyenne is used for CRS caused by medicines known as chimeric antigen receptors (CAR) T-cell medicines.Tyenne can also be used in adults with COVID-19 who are receiving treatment with corticosteroid medicines by mouth or injection and require extra oxygen or mechanical ventilation (breathing assisted by a machine).Tyenne contains the active substance tocilizumab and is a 'biosimilar medicine'. This means thatTyenne is highly similar to another biological medicine (the 'reference medicine') that is alreadyauthorised in the EU. The reference medicine for Tyenne is RoActemra. For more information on biosimilar medicines, see here.

How is Tyenne used?

Tyenne can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the relevant condition.Tyenne is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein. How Tyenne is given, its dose and how often it is given depends on the condition it is used to treat. For COVID-19 and CRS, Tyenne must only be given as an infusion.For more information about using Tyenne, see the package leaflet or contact your doctor or pharmacist.

How does Tyenne work?

The active substance in Tyenne, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body. Tocilizumab attaches to the receptor for a messenger molecule or 'cytokine' called interleukin-6. This messenger is involved in inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, CRS and COVID-19. By preventing interleukin-6 from attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.

What benefits of Tyenne have been shown in studies?

Laboratory studies comparing Tyenne with RoActemra have shown that the active substance in Tyenne is highly similar to that in RoActemra in terms of structure, purity and biological activity. Studies have also shown that giving Tyenne produces similar levels of the active substance in the body to giving RoActemra.In addition, Tyenne was as effective as RoActemra in reducing disease in a study involving 604 adults with moderately to severely active rheumatoid arthritis for whom previous treatment with at least one DMARD had not worked well enough. After 24 weeks of treatment, the DAS28 score (a measure of disease activity in rheumatoid arthritis) had decreased by an average of 3.5 both in patients receiving Tyenne and in those receiving RoActemra.Because Tyenne is a biosimilar medicine, the studies on effectiveness and safety of tocilizumab carried out with RoActemra do not all need to be repeated for Tyenne.

What are the risks associated with Tyenne?

The safety of Tyenne has been evaluated and, based on all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine RoActemra.For the complete list of side effects and restrictions of Tyenne, see the package leaflet.The most common side effects with tocilizumab include upper respiratory tract infections (nose and throat infection) and nasopharyngitis (inflammation of the nose and throat), which may affect more than in 1 in 10 people, and headache, hypertension (high blood pressure) and abnormal liver function tests, which may affect up to in 1 in 10 people. The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions.In patients with COVID-19, the most common side effects with tocilizumab (which may affect up to in1 in 10 people) include abnormal liver function tests, constipation, and urinary tract infections(infections of the parts of the body that collect and pass out urine the structures that carry urine).Tyenne must not be used in patients who have an active, severe infection (except COVID-19). Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe Tyenne with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes.

Why is Tyenne authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Tyenne has a highly similar structure, purity and biological activity to RoActemra and is distributed in the body in the same way. In addition, a study involving patients with rheumatoid arthritis has shown that the safety and effectiveness of Tyenne is equivalent to that of RoActemra in the treatment of this disease.All these data were considered sufficient to conclude that Tyenne will behave in the same way as RoActemra in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for RoActemra, the benefits of Tyenne 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 Tyenne?

The company that markets Tyenne must supply all doctors expected to prescribe the medicine for rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis and giant cell arteritis with an educational pack containing important information on the safety and correct use of Tyenne. The pack will also include a patient alert card with key safety information for patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tyenne have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tyenne a are continuously monitored. Side effects reported with Tyenne are carefully evaluated and any necessary action taken to protect patients.


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Tygacil


What is Tygacil?

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

What is Tygacil used for?

Tygacil is used to treat adults and children older than eight years with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes. It is also used to treat complicated infections in the abdomen. 'Complicated' means that the infection is difficult to treat. Tygacil should be used only when other antibiotics are not suitable. Before using Tygacil, doctors should consider official guidance on the appropriate use of antibiotics.The medicine can only be obtained with a prescription.

How is Tygacil used?

In adults, the recommended dose of Tygacil is a starting dose of 100 mg, followed by 50 mg every 12 hours for five to 14 days. Each infusion should last between 30 and 60 minutes. The length of treatment depends on where the infection is, how severe it is, and the patient's response to treatment. Doses are lower in patients with severe liver problems.In children above eight years of age, treatment is only given after consulting with a doctor with appropriate experience in the management of infectious diseases, and should be given as an infusion over a period of 60 minutes. In children from 8 to 12 years old a dose of 1.2 mg per kilogram bodyweight is given by infusion into a vein every twelve hours, up to a maximum dose of 50 mg every 12 hours. Treatment lasts from 5 to 14 days. In children from 12 to 18 years a dose of 50 mg is given every 12 hours for a period of 5 to 14 days.

How does Tygacil work?

The active substance in Tygacil, tigecycline, belongs to a group of antibiotics called 'glycylcyclines'. It works by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made. By blocking the production of new proteins, the bacteria cannot multiply and they eventually die. The list of bacteria against which Tygacil is active can be found in the summary of product characteristics (also part of the EPAR).

How has Tygacil been studied?

Tygacil has been compared with other antibiotics in four main studies. In two of these studies, Tygacil was compared with the combination of vancomycin and aztreonam in 1,129 patients with complicated skin and soft tissue infections (not including infected diabetic foot ulcers). In the other two studies, Tygacil was compared with imipenem/cilastatin (a combination of two medicines used together as an antibiotic) in 1,568 patients with complicated infections in the abdomen. An additional study compared Tygacil with the antibiotic ertapenem in 813 diabetic patients with moderate to severe foot infections.In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured.

What benefit has Tygacil shown during the studies?

In the four main studies, Tygacil was as effective as the comparator antibiotics. In the studies of skin and soft tissue infections, around 86% of the patients receiving Tygacil were cured, compared with around 89% of those receiving vancomycin and aztreonam. In the studies of abdominal infection, around 86% of the patients receiving either Tygacil or imipenem/cilastatin were cured.In the study looking at diabetic foot infections, Tygacil was less effective than ertapenem: 78% of the patients receiving Tygacil were cured, compared with 83% of those receiving ertapenem.Although there are few data in children, studies suggest that Tygacil can be a treatment alternative for complicated skin and soft tissue or abdominal infections, with bacteria resistant to other antibiotics.

What is the risk associated with Tygacil?

The most common side effects with Tygacil are mild to moderate nausea (feeling sick) and vomiting, seen in 20% and 14% of patients, respectively. For the full list of all side effects reported with Tygacil, see the package leaflet.Tygacil must not be used in people who are hypersensitive (allergic) to tigecycline or any of the other ingredients. Patients allergic to tetracycline antibiotics may also be allergic to Tygacil.

Why has Tygacil been approved?

The CHMP decided that Tygacil'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 Tygacil?

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


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Tyruko


What is Tyruko and what is it used for?

Tyruko is a medicine used in adults to treat highly active multiple sclerosis (MS) that is rapidly getting worse or that is not sufficiently controlled with at least one other disease-modifying therapy (a therapy that can modify the course of the disease).MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding nerves and damages the nerves themselves.Tyruko is used in relapsing-remitting MS, a type of MS in which the patient has attacks (relapses) between periods of stable symptoms (remissions).Tyruko is a 'biosimilar medicine'. This means that Tyruko is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Tyruko is Tysabri. For more information on biosimilar medicines, see here.Tyruko contains the active substance natalizumab.

How is Tyruko used?

The medicine can only be obtained with a prescription and treatment with Tyruko should be started and supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner. This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to a brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with natalizumab and other MS medicines.Tyruko is given as a 1-hour infusion (drip) into a vein once every 4 weeks. Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for 1 hour afterwards. If there is no clear benefit for the patient after 6 months, the doctor should re-assess the treatment with Tyruko.For more information about using Tyruko, see the package leaflet or contact your doctor or pharmacist.

How does Tyruko work?

The active substance in Tyruko, natalizumab, is a monoclonal antibody which targets a protein called α4β1 integrin on white blood cells involved in inflammation. By attaching to this protein, natalizumab is thought to stop white blood cells from entering the brain and spinal cord tissue, thereby reducing inflammation and the resulting nerve damage. This helps to reduce symptoms of the disease.

What benefits of Tyruko have been shown in studies?

Laboratory studies comparing Tyruko with Tysabri have shown that the active substance in Tyruko is highly similar to that in Tysabri in terms of structure, purity and biological activity. Studies have also shown that giving Tyruko produces similar levels of the active substance in the body to giving Tysabri.In addition, a study in 265 patients with relapsing-remitting MS showed that Tyruko produced comparable improvements to those seen with Tysabri. In this study, the average number of new lesions (abnormality) in the brain, as measured by MRI after 24 weeks of treatment, was 1.4 with Tyruko and 1.9 with Tysabri.Because Tyruko is a biosimilar medicine, the studies on effectiveness and safety of natalizumab carried out with Tysabri do not all need to be repeated for Tyruko.

What are the risks associated with Tyruko?

The safety of Tyruko 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 Tysabri.For the complete list of side effects and restrictions of Tyruko, see the package leaflet.Tyruko can increase the risk of infections, including the brain infection PML. PML is a very serious condition that may result in severe disability or death. The risk of PML increases the longer a patient has been receiving Tyruko, especially in patients treated for more than 2 years. The risk is also higher for patients who used medicines that supress the immune system before starting Tyruko, or if the patient has antibodies against the virus that causes PML. If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have this infection.The most common side effects with Tyruko (which may affect more than 1 in 10 people) are urinary tract infection (infection of the parts of the body that carry urine), nasopharyngitis (inflammation of the nose and throat), headache, dizziness, nausea (feeling sick), joint pain and tiredness.Patients may develop long-lasting antibodies against natalizumab, which reduces the medicine's effectiveness.Tyruko must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune system is weakened. It must not be given in combination with other diseasemodifying medicines or to patients who have cancer (unless it is a skin cancer called basal cell carcinoma).

Why is Tyruko authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Tyruko has a highly similar structure, purity and biological activity to Tysabri and is distributed in the body in the same way. In addition, studies in patients with relapsing-remitting MShave shown that the safety and effectiveness of Tyruko is equivalent to that of Tysabri in this indication.All these data were considered sufficient to conclude that Tyruko will behave in the same way as Tysabri in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Tysabri, the benefits of Tyruko 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 Tyruko?

The company that markets Tyruko will agree on measures to improve the monitoring of patients with each Member State. It will also supply all doctors who prescribe Tyruko with an educational pack that includes information on the safety of Tyruko, including information on which patients may be at a higher or lower risk of PML. Patients should receive this information when starting Tyruko, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.Patients who receive Tyruko must be given a special alert card that summarises the key safety information about the medicine. Patients should read this card carefully and keep it with them. Patients should make sure their partner or carer, as well as other doctors treating them, are aware of its content.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tyruko have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tyruko are continuously monitored. Suspected side effects reported with Tyruko are carefully evaluated and any necessary action taken to protect patients.


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Tysabri


What is Tysabri and what is it used for?

Tysabri is a medicine for treating adults with multiple sclerosis (MS) that is not sufficiently controlled with another disease-modifying therapy or is rapidly getting worse.Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding nerves and damages the nerves themselves.Tysabri is used in relapsing-remitting MS, a type of MS in which the patient has attacks (relapses) between periods of stable symptoms (remissions).It contains the active substance natalizumab.

How is Tysabri used?

Treatment with Tysabri should be started and supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner. This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to the brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with Tysabri and other MS medicines.Tysabri is given as a 1-hour infusion (drip) into a vein once every 4 weeks. Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for 1 hour afterwards. If there is no clear benefit for the patient after 6 months, the doctor should re-assess the treatment.The medicine can only be obtained with a prescription.For more information about using Tysabri, see the package leaflet or contact your doctor or pharmacist.

How does Tysabri work?

The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called a4ί1 integrin on white blood cells involved in inflammation. By attaching to integrin, natalizumab isthought to stop white blood cells from entering the brain and spinal cord tissue, thereby reducing inflammation and the resulting nerve damage. This helps to reduce symptoms of the disease.

What benefits of Tysabri have been shown in studies?

Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabritreated patients fell by about 68% after a year, compared with the patients who received placebo. In addition, the risk of disability getting worse was reduced by 42% over 2 years with Tysabri in comparison with placebo.A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses. While the study showed that Tysabri was effective, it also raised concerns that combination with interferon beta-1a increased the risk of the serious brain infection PML.Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from about 2 to 0.2 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used). The response was maintained for up to 5 years.

What are the risks associated with Tysabri?

Tysabri can increase the risk of infections, including the brain infection PML. PML is a very serious condition that may result in severe disability or death. The risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than 2 years. The risk is also higher for patients who used medicines that supress the immune system before starting Tysabri, or if the patient has antibodies against the virus that causes PML. If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.The most common side effects with Tysabri (which may affect more than 1 in 10 people) are urinary tract infection, nasopharyngitis (inflammation of the nose and throat), headache, dizziness, nausea (feeling sick), joint pain and tiredness.About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine's effectiveness.Tysabri must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune system is weakened. It must not be given in combination with other disease-modifying medicines or to patients who have cancer (unless it is a skin cancer called basal cell carcinoma).For the full list of side effects and restrictions of Tysabri, see the package leaflet.

Why is Tysabri authorised in the EU?

Studies have shown that Tysabri is effective in treating relapsing-remitting MS. However, because of its safety risks, it should only be used in patients who have a real need for the medicine either because their disease is not sufficiently controlled with at least one other disease-modifying therapy or is rapidly getting worse.The European Medicines Agency decided therefore that Tysabri's benefits are greater than its risks and it can be authorised for use in the EU.Tysabri Tysabri (natalizumab)

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

The company that markets Tysabri has agreed on measures to improve the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri. It will also supply all doctors who prescribe Tysabri with an educational pack that includes information on the safety of Tysabri, including information on which patients may be at a higher or lower risk of PML. Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.The pack will also include information about other risks of this medicine for patients.Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine. Patients should read this card carefully and keep it with them. Patients should make sure their partner or carer, as well as other doctors treating them, are aware of its content.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tysabri have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tysabri are continuously monitored. Side effects reported with Tysabri are carefully evaluated and any necessary action taken to protect patients.


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Tyverb


What is Tyverb and what is it used for?

Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be'expressing' large amounts of HER2. This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells. Tyverb is used in the following ways:• in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient's metastatic disease with trastuzumab (another cancer medicine). 'Advanced' means that the cancer has started to spread and 'metastatic' means that the cancer has already spread to other parts of the body;• in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);• in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones. This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.Tyverb contains the active substance lapatinib.

How is Tyverb used?

Tyverb can only be obtained with a prescription and should only be started by a doctor who has experience in giving cancer medicines.Tyverb is available as tablets (250 mg) and the recommended dose is 4 tablets a day when used with trastuzumab, 5 tablets a day when it is used with capecitabine, and 6 tablets a day when taken with an aromatase inhibitor. All of the tablets must be taken together at the same time every day, at least 1 hour before or 1 hour after food.The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver. If patients start to take Tyverb again, they mayneed to use a lower dose. Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.For more information about using Tyverb, see the package leaflet or contact your doctor or pharmacist.

How does Tyverb work?

The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors. These medicines work by blocking enzymes known as protein kinases, which can be found in some receptors (targets) on the surface of cancer cells including HER2. HER2 is a receptor for a substance called epidermal growth factor which stimulates the cancer cells to grow uncontrollably. By blocking HER2 receptors, Tyverb helps to control growth of the cancer. About a quarter of breast cancers produce HER2.

What benefits of Tyverb have been shown in studies?

Tyverb in combination with another cancer medicine was shown to be more effective than the comparator treatment in three main studies involving women with breast cancer. In all the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse, which was assessed in scans. The studies also looked at how long the patients survived.The first study compared Tyverb in combination with capecitabine, with capecitabine taken alone. It involved 408 women with advanced or metastatic disease that was producing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back. The women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone. Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.The second study compared Tyverb alone with a combination of Tyverb plus trastuzumab. It involved 296 women with metastatic disease that was producing large quantities of HER2 and got worse despite treatment with trastuzumab and other cancer medicines (including anthracyclines and taxanes). Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone. In addition, women taking the combination survived for 14.0 months on average, compared with 9.5 months in those taking Tyverb alone.The third study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor). It involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones. 219 of the women had cancer that was producing large quantities of HER2. The women had not received trastuzumab or an aromatase inhibitor before entering this study. The women whose cancer was producing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse. This compared with 13.0 weeks in those taking placebo in combination with letrozole.

What are the risks associated with Tyverb?

The most common side effects with Tyverb (which may affect more than 1 in 4 patients) are rash and side effects affecting the stomach and gut (such as diarrhoea, nausea (feeling sick) and vomiting).Palmar-plantar erythrodysaesthesia (rash and numbness on the palms and soles) is also very common when Tyverb is taken with capecitabine. For the full list of side effects and restrictions with Tyverb, see the package leaflet.

Why is Tyverb authorised in the EU?

The European Medicines Agency decided that Tyverb's benefits are greater than its risks and it can be authorised for use in the EU. Tyverb in combination with other cancer medicines has been shown to improve survival of patients with breast cancer that produces large quantities of HER2, and its side effects are considered acceptable.Tyverb was originally given 'conditional approval'. This means that there was more evidence to come about the effectiveness of the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

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

The company that markets Tyverb will evaluate ways to predict resistance (the medicine becoming less effective) in breast cancer patients taking Tyverb with other cancer medicines.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tyverb have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Tyverb are continuously monitored. Side effects reported with Tyverb are carefully evaluated and any necessary action taken to protect patients.


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