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法规知识库 · EMA 集中审评

Sitagliptin / Metformin hydrochloride Sun

sitagliptin fumarate;metformin hydrochloride · EMEA/H/C/005778 · 已授权

仿制药

获批上市许可

2023-03-31

欧委会决定日

2025-04-11

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:A10BD07

治疗领域:Diabetes Mellitus, Type 2

药理分类:Drugs used in diabetes

修订号:2 · 最新影响 PI 的程序:VR/0000263136

适应症(原文):For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin 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。

  1. 2025-04-11 · 欧委会决定

  2. 2023-03-31 · 获批上市许可

  3. 2023-01-26 · 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/Metformin hydrochloride Sun : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-05-06

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  • Sitagliptin/Metformin hydrochloride Sun : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2024-06-06

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  • Sitagliptin/Metformin hydrochloride Sun : EPAR - Medicine overview

    overview · 2023-07-17 · EMA/95270/2023

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  • Sitagliptin/Metformin hydrochloride Sun : EPAR - Risk-management-plan-summary

    rmp-summary · 2023-07-17

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  • Sitagliptin/Metformin hydrochloride Sun : EPAR - Public assessment report

    assessment-report · 2023-07-17 · EMA/290005/2023

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产品信息

  • Sitagliptin/Metformin hydrochloride Sun : EPAR - Product information

    product-information · 2025-05-06

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  • Sitagliptin/Metformin hydrochloride Sun : EPAR - All authorised presentation

    all-authorised-presentations · 2023-07-17

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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。