法规知识库 · EMA 集中审评
Vargatef
nintedanib · EMEA/H/C/002569 · 已授权
获批上市许可
2014-11-21
欧委会决定日
2026-06-10
持有人 / 申请人
Boehringer Ingelheim International GmbH
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：L01EX09
治疗领域：Carcinoma, Non-Small-Cell Lung
药理分类：Antineoplastic agents, protein kinase inhibitors
修订号：22 · 最新影响 PI 的程序：N/0000355233
适应症（原文）：Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.
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。
2026-06-10 · 欧委会决定
2014-11-21 · 获批上市许可
2014-09-25 · 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
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Vargatef : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-10
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Vargatef : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-10
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Vargatef : EPAR - Risk management plan
rmp · 2026-03-19
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Vargatef-H-C-PSUSA-00010318-202210 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-11-13 · EMA/509938/2023
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Vargatef-H-C-PSUSA-00010318-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-08-18 · EMA/428921/2020
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Vargatef-H-C-PSUSA-00010318-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-07 · EMA/CHMP/601091/2019
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Vargatef-H-C-PSUSA-00010318-201710 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-08-03 · EMA/524347/2018
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Vargatef-H-C-PSUSA-00010318-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-09-19 · EMA/612471/2017
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Vargatef-H-C-PSUSA-00010318-201605 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-03-02 · EMA/152931/2017
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Vargatef-H-C-PSUSA-00010318-201511 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-09-28 · EMA/563357/2016
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Vargatef : EPAR - Summary for the public
overview · 2015-01-08 · EMA/601036/2014
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Vargatef : EPAR - Public assessment report
assessment-report · 2015-01-08 · EMA/CHMP/726072/2014
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。