法规知识库 · EMA 集中审评
Alimta
pemetrexed · EMEA/H/C/000564 · 已授权
获批上市许可
2004-09-20
欧委会决定日
2026-01-16
持有人 / 申请人
Eli Lilly Nederland B.V.
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01BA04
治疗领域：Mesothelioma;Carcinoma, Non-Small-Cell Lung
药理分类：Antineoplastic agents
修订号：30 · 最新影响 PI 的程序：VR/0000315508
适应症（原文）：Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma. Non-small-cell lung cancer Alimta 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. Alimta 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. Alimta 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。
2026-01-16 · 欧委会决定
2004-09-20 · 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
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Alimta : EPAR - Risk management plan
rmp · 2026-08-18
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Alimta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-16
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Alimta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-16
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Alimta-H-C-PSUSA-00002330-202402: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-03-05 · EMA/42489/2025
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Alimta-H-C-PSUSA-00002330-201802: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-04-10 · EMA/798348/2018
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Alimta-H-C-PSUSA-00002330-201502: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-01-28 · EMA/816446/2015
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Alimta-H-C-564-II-33 : EPAR - Assessment Report - Variation
variation-report · 2011-12-09 · EMA/850371/2011
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Alimta : EPAR - Summary for the public
overview · 2011-12-09
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Alimta-H-C-564-II-15 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2009-09-08
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Alimta-H-C-564-II-09 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-05-08
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Alimta : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-02-09
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Alimta : EPAR - Scientific Discussion
scientific-discussion · 2006-02-09
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。