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法规知识库 · EMA 集中审评

Pemetrexed Fresenius Kabi

pemetrexed · EMEA/H/C/003895 · 已授权

仿制药

获批上市许可

2016-07-22

欧委会决定日

2024-12-19

持有人 / 申请人

Fresenius Kabi Deutschland GmbH

终止日期字段

无

从产品到官方文件

文件记录

6

官方索引 6

EPAR / 审评

4

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:Antineoplastic agents

修订号:15 · 最新影响 PI 的程序:PSUSA/00002330/202402

适应症(原文):Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi 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 Fresenius Kabi 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 Fresenius Kabi 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. 2024-12-19 · 欧委会决定

  2. 2016-07-22 · 获批上市许可

  3. 2016-05-26 · 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 4产品信息 2其他 0

EPAR / 审评资料

  • Pemetrexed Fresenius Kabi-PSUSA-00002330-202402 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2025-02-12 · EMA/42489/2025

    打开官方文件 ↗
  • Pemetrexed Fresenius Kabi : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-02-12

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  • Pemetrexed Fresenius Kabi : EPAR - Public assessment report

    assessment-report · 2016-07-26 · EMA/CHMP/407425/2016

    打开官方文件 ↗
  • Pemetrexed Fresenius Kabi : EPAR - Summary for the public

    overview · 2016-07-26 · EMA/372827/2016

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产品信息

  • Pemetrexed Fresenius Kabi : EPAR - Product Information

    product-information · 2025-02-12

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  • Pemetrexed Fresenius Kabi : EPAR - All Authorised presentations

    all-authorised-presentations · 2020-07-16

    打开官方文件 ↗

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。