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法规知识库 · EMA 集中审评

Sitagliptin SUN

sitagliptin fumarate · EMEA/H/C/005741 · 已授权

仿制药

获批上市许可

2021-12-09

欧委会决定日

2026-08-20

持有人 / 申请人

Sun Pharmaceutical Industries Europe B.V.

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

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:4 · 最新影响 PI 的程序:R/0000335931

适应症(原文):For adult patients with type 2 diabetes mellitus, Sitagliptin SUN 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. Sitagliptin SUN 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. 2026-08-20 · 欧委会决定

  2. 2021-12-09 · 获批上市许可

  3. 2021-10-14 · 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 5产品信息 2其他 0

EPAR / 审评资料

  • Sitagliptin SUN : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-10-27

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  • Sitagliptin SUN : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-02-26

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  • Sitagliptin SUN : EPAR - Medicine overview

    overview · 2022-01-17 · EMA/604084/2021

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  • Sitagliptin SUN : EPAR - Public assessment report

    assessment-report · 2022-01-17 · EMA/611380/2021

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  • Sitagliptin SUN : EPAR - Risk management plan summary

    rmp-summary · 2022-01-17

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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。