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法规知识库 · EMA 集中审评

Pemetrexed Baxter

pemetrexed disodium heptahydrate · EMEA/H/C/005848 · 已撤市

仿制药

获批上市许可

2022-12-09

欧委会决定日

2022-12-09

持有人 / 申请人

Baxter Holding B.V.

终止日期字段

2025-05-02

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:L01BA04

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

药理分类:Antineoplastic agents

修订号:— · 最新影响 PI 的程序:—

适应症(原文):Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter 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 (see section 5.1). Pemetrexed Baxter 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 (see section 5.1). Pemetrexed Baxter 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 (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. 2025-05-02 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2022-12-09 · 欧委会决定

  3. 2022-12-09 · 获批上市许可

  4. 2022-10-13 · 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 3产品信息 2其他 0

EPAR / 审评资料

  • Pemetrexed Baxter : EPAR - Medicine overview

    overview · 2026-09-28 · EMA/841935/2022

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  • Pemetrexed Baxter : EPAR - Risk management plan summary

    rmp-summary · 2026-09-28

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  • Pemetrexed Baxter : EPAR - Public Assessment Report

    assessment-report · 2026-09-28 · EMA/CHMP/251833/2022

    打开官方文件 ↗

产品信息

  • Pemetrexed Baxter : EPAR - Product Information

    product-information · 2026-09-28

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  • Pemetrexed Baxter : EPAR - All authorised presentations

    all-authorised-presentations · 2026-09-28

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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。