| Medicine Name (İlaç Adı): | Mvasi | Therapeutic Area (Terapötik Bölge): | Carcinoma, Renal Cell, Peritoneal Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Fallopian Tube Neoplasms |
| Active Substance (Aktif Madde): | bevacizumab | Product Number (Ürün Numarası): | EMEA/H/C/004728 |
| ATC Code (ATC Kodu): | L01XC07 | Authorisation Status (Yetkilendirme Durumu): | Authorised |
| International Non-Proprietary Name (INN) / Ortak İsim: | bevacizumab | Additional Monitoring (Ek İzleme): | yes |
| Generic (Jenerik): | no | Biosimilar (Biyobenzer): | yes |
| Conditional Approval (Şartlı Onay): | no | Exceptional Circumstances (İstisnai Durumlar): | no |
| Accelerated Assessment (Hızlandırılmış Değerlendirme): | no | Orphan Medicine (Nadir Hastalık İlacı): | no |
| Marketing Authorisation Date (Pazarlama Yetkilendirme Tarihi): | 15.01.2018 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Amgen Europe B.V. |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Antineoplastic agents, | Decision Date (Görüş Tarihi): | 30.10.2019 |
| Condition / İndication (Şart / Edikasyon): | Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.Mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status.Mvasi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.Mvasi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.Mvasi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.Mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix. | First Published (İlk Yayın Tarihi): | 12.02.2018 |
| Revision Date (Revizyon Tarihi): | 5 | Revision Date (Revizyon Tarihi): | 12.11.2019 |
| EPAR (Avrupa Kamu Değerlendirme Raporları): |
Avrupa Birliği - Avrupa İlaç Ajansı (European Medicines Agency) tarafından hazırlanan Avrupa Birliği düzeyinde izin verilen ilaçların bilgilerine yer verilmektedir. EPAR (Avrupa Kamu Değerlendirme Raporları) kısmında yer alan linkten, Avrupa Birliği düzeyinde izin verilen ilaçların tam bilimsel değerlendirme raporlarına, ilaç içerikleri, ilaçların ne için kullanıldıkları, nasıl kullanıldıkları, ilacın nasıl çalıştığı, ilacın nasıl araştırıldığı, çalışmalar sırasında ilacın ne faydası olduğu, ilacın riskleri, ilacın neden onaylandığı, ilaç hakkında diğer genel bilgilere yer verilmektedir. Ayrıca ilacın yetkilendirme bilgileri, ürün bilgisi ve değerlendirme geçmişi bilgileri de yer almaktadır. EPAR'lar ayrıca soru-cevap biçiminde ve paket broşüründe halka açık bir genel bakış içerir. Pazarlama iznini reddetmiş veya onaylandıktan sonra askıya alınmış veya geri çekilmiş ilaçlar hakkında bilgi de bulabilirsiniz.
