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法规知识库 · EMA 集中审评

Pemetrexed medac

pemetrexed · EMEA/H/C/003905 · 已撤市

仿制药

获批上市许可

2015-11-26

欧委会决定日

2025-05-28

持有人 / 申请人

medac Gesellschaft für klinische Spezialpräparate mbH

终止日期字段

2026-08-28

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01BA04

治疗领域:Carcinoma, Non-Small-Cell Lung;Mesothelioma

药理分类:Folic acid analogues;Antineoplastic agents

修订号:9 · 最新影响 PI 的程序:VR/0000261770

适应症(原文):Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

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. 2026-08-28 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2025-05-28 · 欧委会决定

  3. 2015-11-26 · 获批上市许可

  4. 2015-09-23 · CHMP 意见通过

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 5产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-10-26

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  • Pemetrexed medac : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2026-10-26

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  • Pemetrexed medac : EPAR - Summary for the public

    overview · 2026-10-26 · EMA/635350/2015

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  • Pemetrexed medac : EPAR - Public assessment report

    assessment-report · 2026-10-26 · EMA/671085/2015

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  • Pemetrexed medac : EPAR - Risk-management-plan summary

    rmp-summary · 2026-10-26 · EMA/666615/2015

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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。