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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。

  1. 2025-10-30 · 欧委会决定

  2. 2010-03-15 · 获批上市许可

  3. 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 10产品信息 2其他 0

EPAR / 审评资料

  • 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

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  • 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

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  • 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

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产品信息

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。