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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。

  1. 2010-03-01 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2009-07-14 · 欧委会决定

  3. 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 7产品信息 2其他 0

EPAR / 审评资料

  • Paxene : EPAR - Summary for the public

    overview · 2010-03-22

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  • Paxene : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2010-03-22

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  • Paxene : EPAR - Scientific Discussion

    scientific-discussion · 2010-03-22

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  • Paxene : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2010-03-22

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  • Paxene-H-C-399-II-25 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2010-03-22

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  • Paxene-H-C-399-II-26 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2010-03-22

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  • Paxene : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2010-03-22

    打开官方文件 ↗

产品信息

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。