Tecentriq Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

tecentriq

roche registration gmbh - ατεζολιζουμάμπη - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - Αντινεοπλασματικοί παράγοντες - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq ως μονοθεραπεία ενδείκνυται για τη θεραπεία ενηλίκων ασθενών με τοπικά προχωρημένο ή μεταστατικό μη μικροκυτταρικό καρκίνο του πνεύμονα, μετά από προηγούμενη χημειοθεραπεία. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq ως μονοθεραπεία ενδείκνυται για τη θεραπεία ενηλίκων ασθενών με τοπικά προχωρημένο ή μεταστατικό μη μικροκυτταρικό καρκίνο του πνεύμονα, μετά από προηγούμενη χημειοθεραπεία. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

COSYREL 10MG/10MG FILM COATED TABLETS Κύπρος - Ελληνικά - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

cosyrel 10mg/10mg film coated tablets

les laboratoires servier (0000003392) 50 rue carnot, suresnes cedex, 92284 - bisoprolol fumarate; perindopril arginine - film coated tablets - 10mg/10mg - bisoprolol fumarate (0066722450) 10mg; perindopril arginine (8000002204) 10mg - perindopril and bisoprolol

COSYREL 5MG/5MG FILM COATED TABLETS Κύπρος - Ελληνικά - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

cosyrel 5mg/5mg film coated tablets

les laboratoires servier (0000003392) 50 rue carnot, suresnes cedex, 92284 - bisoprolol fumarate; perindopril arginine - film coated tablets - 5mg/5mg - bisoprolol fumarate (0066722450) 5mg; perindopril arginine (8000002204) 5mg - perindopril and bisoprolol

Hemlibra Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

hemlibra

roche registration limited - emicizumab - Αιμορροφιλία Α - Αντιαιμορραγικά - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra μπορεί να χρησιμοποιηθεί σε όλες τις ηλικιακές ομάδες.

Pelmeg Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

pelmeg

mundipharma corporation (ireland) limited - pegfilgrastim - Ουδετεροπενία - Ανοσοδιεγερτικά, - Για να μειωθεί η διάρκεια της ουδετεροπενίας και της επίπτωσης της εμπύρετης ουδετεροπενίας λόγω χημειοθεραπείας.

Cegfila (previously Pegfilgrastim Mundipharma) Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

cegfila (previously pegfilgrastim mundipharma)

mundipharma corporation (ireland) limited - pegfilgrastim - Ουδετεροπενία - Ανοσοδιεγερτικά, - Μείωση της διάρκειας της ουδετεροπενίας και τη συχνότητα της εμπύρετης ουδετεροπενίας σε ενήλικες ασθενείς που έλαβαν θεραπεία με κυτταροτοξική χημειοθεραπεία για κακοήθεια (με εξαίρεση τα χρόνια μυελογενή λευχαιμία και μυελοδυσπλαστικά σύνδρομα).

Polivy Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab vedotin - Το Λέμφωμα Β-Κυττάρων - Αντινεοπλασματικοί παράγοντες - polivy σε συνδυασμό με bendamustine και rituximab ενδείκνυται για τη θεραπεία ενήλικων ασθενών με υποτροπιάζον/ανθεκτικό διάχυτο από μεγάλα Β-κύτταρα λέμφωμα (dlbcl) που δεν είναι υποψήφιοι για αιματοποιητική μεταμόσχευση βλαστικών κυττάρων. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Rozlytrek Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

rozlytrek

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Αντινεοπλασματικοί παράγοντες - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Xofluza Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

xofluza

roche registration gmbh - baloxavir marboxil - Γρίπη, Ανθρώπινα - Αντιιικά για συστηματική χρήση - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Phesgo Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - Νεοπλάσματα του μαστού - Αντινεοπλασματικοί παράγοντες - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.