Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

genentech inc u.s.a. 460 point san bruno boulevard, south san francisco ca 94080 415 266 1000 - atezolizumab - inj.so.inf (ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ ΓΙΑ ΕΝΔΟΦΛΕΒΙΑ ΕΓΧΥΣΗ) - 1200mg/20ml - atezolizumab 1.200mg - monoclonal antibodies

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

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.

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohn Νόσος - Ανοσοδιεγερτικά, - Θεραπεία της μέτρια έως σοβαρή ενεργό νόσο του crohn για τη μείωση των σημείων και συμπτωμάτων, καθώς και την επαγωγή και διατήρηση της παρατεταμένης ανταπόκρισης και ύφεσης σε ασθενείς που δεν έχουν ανταποκριθεί σε πλήρη, επαρκή θεραπευτική αγωγή κε ένα κορτικοστεροειδές και ένα ανοσοκατασταλτικό, ή έχουν δυσανεξία ή αντένδειξη για τέτοιες θεραπείες.

Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

takeda pharma a/s, taastrup, denmark dybendal alle 10, 2630 taastrup - vedolizumab - pd.c.so.in (ΚΟΝΙΣ ΓΙΑ ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/vial - vedolizumab 300mg - vedolizumab

Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

eculizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/30ml (10mg/ml) - eculizumab 300mg - eculizumab

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - Πολλαπλή σκλήρυνση - Επιλεκτικά ανοσοκατασταλτικά - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 και 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - Ασθμα - Φάρμακα αποφρακτικών παθήσεων των αναπνευστικών οδών, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ανοσοκατασταλτικά - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 και 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

takeda pharma a/s - βενολιζουμάμπη - colitis, ulcerative; crohn disease - Επιλεκτικά ανοσοκατασταλτικά - Ελκώδης colitisentyvio ενδείκνυται για τη θεραπεία ενήλικων ασθενών με μέτρια έως σοβαρή ενεργό ελκώδη κολίτιδα, οι οποίοι είχαν ανεπαρκή απόκριση, έχασαν την ανταπόκριση ή δυσανεξία είτε συμβατική θεραπεία ή του παράγοντα νέκρωσης όγκων άλφα (tnfa) ανταγωνιστής. Νόσος του crohn diseaseentyvio ενδείκνυται για τη θεραπεία ενήλικων ασθενών με μέτρια έως σοβαρή ενεργό νόσο του crohn, οι οποίοι είχαν ανεπαρκή απόκριση, έχασαν την ανταπόκριση ή δυσανεξία είτε συμβατική θεραπεία ή του παράγοντα νέκρωσης όγκων άλφα (tnfa) ανταγωνιστής. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

elan pharma international ltd, athlone, ireland - natalizumab - ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ - 300mg/vial (20mg/ml) - ΒΙΟΛΟΓΙΚΟ ΠΡΟΙΟΝ (ΒΠ)