法规知识库 · EMA 集中审评
Efficib
sitagliptin;metformin hydrochloride · EMEA/H/C/000896 · 已授权
获批上市许可
2008-07-15
欧委会决定日
2025-11-27
持有人 / 申请人
Merck Sharp and Dohme B.V
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
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：37 · 最新影响 PI 的程序：N/0000314786
适应症（原文）：For patients with type-2 diabetes mellitus: Efficib 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. Efficib 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. Efficib is indicated as triple combination therapy with a 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. Efficib 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 dosage 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。
2025-11-27 · 欧委会决定
2008-07-15 · 获批上市许可
2008-04-24 · 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 ↗
Efficib : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-01
- 打开官方文件 ↗
Efficib : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-28
- 打开官方文件 ↗
Efficib : EPAR - Risk-management-plan summary
rmp-summary · 2022-05-31
- 打开官方文件 ↗
Efficib-H-C-896-WS-1898 : EPAR - Assessment Report - Variation
variation-report · 2020-12-17 · EMA/603247/2020
- 打开官方文件 ↗
Efficib-H-C-PSUSA-00002003-201708 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-07-02 · EMA/423583/2018
- 打开官方文件 ↗
Efficib : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-22
- 打开官方文件 ↗
Efficib-H-C-896-A31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2016-12-22 · EMA/CHMP/539626/2016
- 打开官方文件 ↗
Efficib : EPAR - Summary for the public
overview · 2013-07-05
- 打开官方文件 ↗
Efficib-H-C-896-II-0004 : EPAR - Assessment Report - Variation
variation-report · 2009-12-08 · EMEA/752888/2009
- 打开官方文件 ↗
Efficib-H-C-896-II-0013 : EPAR - Assessment Report - Variation
variation-report · 2009-07-06 · EMEA/350880/2009
- 打开官方文件 ↗
Efficib : EPAR - Public assessment report
assessment-report · 2008-08-06
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。