法规知识库 · EMA 集中审评
Ristaben
sitagliptin · EMEA/H/C/001234 · 已授权
获批上市许可
2010-03-15
欧委会决定日
2025-10-30
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:A10BH01
治疗领域:Diabetes Mellitus, Type 2
药理分类:Drugs used in diabetes
修订号:30 · 最新影响 PI 的程序:N/0000309220
适应症(原文):For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin 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。
2025-10-30 · 欧委会决定
2010-03-15 · 获批上市许可
2009-12-17 · 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 ↗
Ristaben : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-10-30
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Ristaben : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-30
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Ristaben-PAM-0000244494 : EPAR - Assessment report
variation-report · 2025-06-27 · EMADOC-1700519818-1838618
- 打开官方文件 ↗
Ristaben : EPAR - Risk management plan summary
rmp-summary · 2022-07-01
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Ristaben : EPAR - Paediatric-investigation-plan compliance statement
pip-compliance · 2020-04-01 · EMEA/H/C/001234/IB/0061
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Ristaben-H-C-PUSA-0002711-01708 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-06-22 · EMA/423578/2018
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Ristaben-H-C-PSUSA-00002711-201408 : EPAR - Scientific conclusions and grounds recommending the variation
scientific-conclusion · 2015-07-14 · EMA/304624/2015
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Ristaben : EPAR - Summary for the public
overview · 2015-03-09
- 打开官方文件 ↗
Ristaben-H-C-1234-P46-0011 : EPAR - Assessment Report
variation-report · 2013-04-02 · EMA/191054/2013
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Ristaben : EPAR - Public assessment report
assessment-report · 2010-03-29
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。