法规知识库 · EMA 集中审评
Docetaxel Teva Pharma
docetaxel · EMEA/H/C/002032 · 已失效
获批上市许可
2011-01-21
欧委会决定日
2014-01-21
持有人 / 申请人
Teva Pharma B.V.
终止日期字段
2014-01-21
从产品到官方文件
文件记录
5
官方索引 5
EPAR / 审评
3
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01CD02
治疗领域：Carcinoma, Non-Small-Cell Lung;Breast Neoplasms;Prostatic Neoplasms
药理分类：Antineoplastic agents
修订号：6 · 最新影响 PI 的程序：IB/7/G
适应症（原文）：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.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2014-01-21 · 欧委会决定
2014-01-21 · 上市许可终止（撤市/失效/撤销等）
Lapsed
2011-01-21 · 获批上市许可
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Docetaxel Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2014-01-29
- 打开官方文件 ↗
Docetaxel Teva Pharma : EPAR - Public assessment report
assessment-report · 2014-01-29 · EMA/32518/2011
- 打开官方文件 ↗
Docetaxel Teva Pharma : EPAR - Summary for the public
overview · 2014-01-29 · EMA/698861/2010
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。