| 商品名称 | Docetaxel Teva Pharma |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Carcinoma, Non-Small-Cell Lung;Breast Neoplasms;Prostatic Neoplasms |
| 通用名/非专利名称 | docetaxel |
| 活性成分 | docetaxel |
| 产品号 | EMEA/H/C/002032 |
| 患者安全信息 | No |
| 许可状态 | Lapsed |
| 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 | 2011/01/21 |
| 上市许可开发者/申请人/持有人 | Teva Pharma B.V. |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2014/01/21 |
| 修订号 | 6 |
| 治疗适应症 | Breast cancer Docetaxel Teva Pharma 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. Non-small-cell lung cancer Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva Pharma 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 Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2014/01/21 |
| 最后更新日期 | 2014/01/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/docetaxel-teva-pharma-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-teva-pharma |