欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Docetaxel Teva
适用类别Human
治疗领域Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms
通用名/非专利名称docetaxel
活性成分docetaxel
产品号EMEA/H/C/001107
患者安全信息No
许可状态Withdrawn
ATC编码L01CD02
是否额外监管No
是否仿制药或hybrid药物Yes
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2010/01/26
上市许可开发者/申请人/持有人Teva B.V. 
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2009/11/19
欧盟委员会决定日期2020/04/28
修订号18
治疗适应症Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Teva 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 Teva 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 Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva 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 cancer Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva 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 cancer Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Teva 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 cancer Docetaxel Teva 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.
适用物种
兽用药物ATC编码
首次发布日期2018/06/25
最后更新日期2021/12/14
产品说明书https://www.ema.europa.eu/en/documents/product-information/docetaxel-teva-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-teva
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