法规知识库 · EMA 集中审评
Sitagliptin Accord
sitagliptin hydrochloride · EMEA/H/C/005598 · 已授权
获批上市许可
2022-04-25
欧委会决定日
2025-01-24
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
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:1 · 最新影响 PI 的程序:IB/0003/G
适应症(原文):For adult patients with type 2 diabetes mellitus, Sitagliptin Accord 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 (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy 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 PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin Accord 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。
2025-01-24 · 欧委会决定
2022-04-25 · 获批上市许可
2022-02-24 · 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 ↗
Sitagliptin Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-01-27
- 打开官方文件 ↗
Sitagliptin Accord : EPAR - Medicine overview
overview · 2022-07-05 · EMEA/H/C/005598
- 打开官方文件 ↗
Sitagliptin Accord : EPAR - Risk-management-plan summary
rmp-summary · 2022-07-05
- 打开官方文件 ↗
Sitagliptin Accord : EPAR - Public Assessment Report
assessment-report · 2022-07-05 · EMA/128895/2022
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。