法规知识库 · EMA 集中审评
Entyvio
vedolizumab · EMEA/H/C/002782 · 已授权
获批上市许可
2014-05-22
欧委会决定日
2026-01-15
持有人 / 申请人
Takeda Pharma A/S
终止日期字段
无
从产品到官方文件
文件记录
22
官方索引 22
EPAR / 审评
20
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：—
治疗领域：Colitis, Ulcerative;Crohn Disease
药理分类：Immunosuppressants;Monoclonal antibodies
修订号：34 · 最新影响 PI 的程序：VR/0000255408
适应症（原文）：Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
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。
2026-01-15 · 欧委会决定
2014-05-22 · 获批上市许可
2014-03-20 · 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
- 打开官方文件 ↗
Entyvio-PAM-0000322264 : EPAR - Assessment report
variation-report · 2026-11-06 · EMADOC-1700519818-2800211
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Entyvio-PAM-0000350559 : EPAR - Assessment report
variation-report · 2026-11-06 · EMADOC-1700519818-3202436
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Entyvio-PAM-0000323359 : EPAR - Assessment report
variation-report · 2026-06-15 · EMADOC-1700519818-3226014
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Entyvio : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-03
- 打开官方文件 ↗
Entyvio : EPAR - Risk-management-plan
rmp · 2026-03-03
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Entyvio-PAM-0000291233 : EPAR - Assessment report
variation-report · 2026-02-23 · EMADOC-1700519818-2408036
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Entyvio-H-C-PSUSA-00010186-202405 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-04-11 · EMA/23738/2025
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Entyvio : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-11
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Entyvio-H-C-002782-X-0075 : EPAR - Assessment report - Variation
variation-report · 2024-02-28 · EMA/22098/2024
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Entyvio : EPAR - Summary for the public
overview · 2023-11-09 · EMA/3386/2022
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Entyvio-H-C-002782-P46-008 : EPAR - Assessment report
variation-report · 2023-03-01 · EMA/3254/2023
- 打开官方文件 ↗
Entyvio-H-C-2782-II-0061 : EPAR - Assessment report - Variation
variation-report · 2022-03-01 · EMA/13745/2022
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Entyvio-H-C-PSUSA-00010186-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-07-16
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Entyvio-H-C-2782-X-0040 : EPAR - Assessment report - Variation
variation-report · 2020-05-18 · EMA/220524/2020
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Entyvio-H-C-2782-P46-004.1 : EPAR - Assessment report
variation-report · 2020-04-23 · EMA/154686/2020
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Entyvio-H-C-2782-P46-004 : EPAR - Assessment report
variation-report · 2019-08-12 · EMA/161185/2019
- 打开官方文件 ↗
Entyvio-H-C-PSUSA-00010186-201805 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-04-01
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Entyvio-H-C-PSUSA-00010186-201711 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-02-12 · EMA/101112/2019
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Entyvio-H-C-PSUSA-00010186-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-03-01 · EMA/134079/2018
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Entyvio : EPAR - Public assessment report
assessment-report · 2014-06-16 · EMA/CHMP/676643/2013
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。