法规知识库 · EMA 集中审评
Stivarga
regorafenib · EMEA/H/C/002573 · 已授权
获批上市许可
2013-08-26
欧委会决定日
2026-02-26
持有人 / 申请人
Bayer Pharma AG
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EX05
治疗领域：Colorectal Neoplasms
药理分类：Antineoplastic agents;Protein kinase inhibitors
修订号：24 · 最新影响 PI 的程序：VR/0000312922
适应症（原文）：Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
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。
2026-02-26 · 欧委会决定
2013-08-26 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Stivarga : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-03-24 · EMADOC-1700519818-2940864
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Stivarga : EPAR - Risk management plan
rmp · 2026-03-24
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Stivarga : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-24
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Stivarga : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-02
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Stivarga-H-C-2573-P46-014 : EPAR - Assessment report
variation-report · 2025-02-07 · EMA/CHMP/542864/2024
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Stivarga-H-C-PSUSA-00010133-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-09-10 · EMA/500298/2021
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Stivarga-H-C-PSUSA-00010133-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-07-19 · EMA/495676/2018
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Stivarga-H-C-2573-II-0020 : EPAR - Assessment Report - Variation
variation-report · 2017-09-01 · EMA/467788/2017
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Stivarga : EPAR - Summary for the public
overview · 2017-09-01 · EMA/525123/2013
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Stivarga-H-C-PSUSA-00010133-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-06-16 · EMA/384182/2017
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Stivarga-H-C-PSUV-0004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-01-22 · EMA/CHMP/648427/2014
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Stivarga-H-C-2573-II-0001 : EPAR - Assessment Report - Variation
variation-report · 2014-09-18 · EMA/CHMP/348464/2014
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Stivarga : EPAR - Public assessment report
assessment-report · 2013-09-12 · EMA/CHMP/403683/2013
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。