法规知识库 · EMA 集中审评
Revestive
teduglutide · EMEA/H/C/002345 · 已授权
获批上市许可
2012-08-30
欧委会决定日
2025-05-22
持有人 / 申请人
Takeda Pharmaceuticals International AG Ireland
终止日期字段
无
从产品到官方文件
文件记录
19
官方索引 19
EPAR / 审评
16
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A16AX08
治疗领域：Malabsorption Syndromes
药理分类：Other alimentary tract and metabolism products
修订号：27 · 最新影响 PI 的程序：N/0000272450
适应症（原文）：Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.
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。
2025-05-22 · 欧委会决定
2012-08-30 · 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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Revestive : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-23
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Revestive : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-23
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Revestive-H-C-002345-P46-015 : EPAR - Assessment report
variation-report · 2024-08-21 · EMA/CHMP/221100/2024
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Revestive-H-C-002345-P46-014 : EPAR - Assessment report
variation-report · 2024-04-03 · EMA/CHMP/33643/2024
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Revestive : EPAR - Risk management plan
rmp · 2024-03-06
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Revestive-H-C-2345-P46-013.1 : EPAR - Assessment Report
variation-report · 2023-07-27 · EMA/514430/2021
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Revestive-H-C-2345-II-0054-G : EPAR - Assessment Report - Variation
variation-report · 2023-07-11 · EMA/281521/2023
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Revestive : EPAR - Summary for the public
overview · 2023-07-11 · EMA/217413/2023
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Revestive-H-C-2345-P46-012 : EPAR - Assessment Report
variation-report · 2022-03-01 · EMA/CHMP/550184/2021
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Revestive-H-C-2345-II-0053 : EPAR - Assessment Report - Variation
variation-report · 2022-01-11 · EMA/717241/2021
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Revestive : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2022-01-11 · EMA/654654/2021
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Revestive-H-C-2345-P46-011 : EPAR - Assessment Report
variation-report · 2021-10-26 · EMA/455323/2021
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Revestive-H-C-PSUSA-00009305-201908 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-06-09 · EMA/271458/2020
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Revestive-H-C-2345-II-43 : EPAR - Assessment Report - Variation
variation-report · 2019-04-29 · EMA/225706/2019
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Revestive-H-C-2345-II-20 : EPAR - Assessment Report - Variation
variation-report · 2016-08-03 · EMA/531666/2016
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Revestive : EPAR - Public assessment report
assessment-report · 2012-09-24 · EMA/CHMP/525255/2012
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。