法规知识库 · EMA 集中审评
Vipdomet
alogliptin benzoate;metformin hydrochloride · EMEA/H/C/002654 · 已授权
获批上市许可
2013-09-18
欧委会决定日
2025-05-19
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
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BD13
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes;Combinations of oral blood glucose lowering drugs
修订号：13 · 最新影响 PI 的程序：VR/0000263319
适应症（原文）：Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin; in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone; in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
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。
2025-05-19 · 欧委会决定
2013-09-18 · 获批上市许可
2013-07-25 · 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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Vipdomet : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-19
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Vipdomet : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-19
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Vipdomet : EPAR - Risk Management Plan
rmp · 2024-01-31
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Vipdomet-H-C-PSUSA-00010061-202004: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-03-04 · EMA/134473/2021
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Vipdomet : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-21
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Vipdomet-H-C-2654-A31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2016-12-21 · EMA/867221/2016
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Vipdomet-H-C-2654-PSUV-0008: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-01-28 · EMA/CHMP/26417/2015
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Vipdomet : EPAR - Public assessment report
assessment-report · 2013-10-14 · EMA/CHMP/207158/2013
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Vipdomet : EPAR - Summary for the public
overview · 2013-10-14 · EMA/472049/2013
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。