法规知识库 · EMA 集中审评
Paxene
paclitaxel · EMEA/H/C/000216 · 已撤市
获批上市许可
1999-07-19
欧委会决定日
2009-07-14
持有人 / 申请人
Norton Healthcare Ltd.
终止日期字段
2010-03-01
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01CD01
治疗领域:Sarcoma, Kaposi;Carcinoma, Non-Small-Cell Lung;Ovarian Neoplasms;Breast Neoplasms
药理分类:Antineoplastic agents
修订号:14 · 最新影响 PI 的程序:R/0047
适应症(原文):Paxene is indicated for the treatment of patients with: advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).
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。
2010-03-01 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2009-07-14 · 欧委会决定
1999-07-19 · 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 ↗
Paxene : EPAR - Summary for the public
overview · 2010-03-22
- 打开官方文件 ↗
Paxene : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2010-03-22
- 打开官方文件 ↗
Paxene : EPAR - Scientific Discussion
scientific-discussion · 2010-03-22
- 打开官方文件 ↗
Paxene : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2010-03-22
- 打开官方文件 ↗
Paxene-H-C-399-II-25 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2010-03-22
- 打开官方文件 ↗
Paxene-H-C-399-II-26 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2010-03-22
- 打开官方文件 ↗
Paxene : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2010-03-22
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。