| Medicine Name (İlaç Adı): | Docefrez | Therapeutic Area (Terapötik Bölge): | Stomach Neoplasms, Adenoma, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms |
| Active Substance (Aktif Madde): | docetaxel | Product Number (Ürün Numarası): | EMEA/H/C/001074 |
| ATC Code (ATC Kodu): | L01CD02 | Authorisation Status (Yetkilendirme Durumu): | Withdrawn |
| International Non-Proprietary Name (INN) / Ortak İsim: | docetaxel | Additional Monitoring (Ek İzleme): | no |
| Generic (Jenerik): | yes | Biosimilar (Biyobenzer): | no |
| 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): | 10.05.2010 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Sun Pharmaceutical Industries Europe B.V. |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Antineoplastic agents, | Decision Date (Görüş Tarihi): | 25.05.2012 |
| Condition / İndication (Şart / Edikasyon): | Breast cancerDocetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small cell lung cancerDocetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. | First Published (İlk Yayın Tarihi): | 25.05.2012 |
| Revision Date (Revizyon Tarihi): | 1 | Revision Date (Revizyon Tarihi): | 14.06.2012 |
| 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.
