法规知识库 · EMA 集中审评
Jentadueto
linagliptin;metformin · EMEA/H/C/002279 · 已授权
获批上市许可
2012-07-19
欧委会决定日
2026-06-05
持有人 / 申请人
Boehringer Ingelheim International GmbH
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BD11
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：26 · 最新影响 PI 的程序：EMA/N/0000350102
适应症（原文）：Treatment of adult patients with type-2 diabetes mellitus: Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
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。
2026-06-05 · 欧委会决定
2012-07-19 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Jentadueto : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-08
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Jentadueto : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-08
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Jentadueto-H-C-2279-II-0070 : EPAR - Assessment Report - Variation
variation-report · 2024-04-22 · EMA/167968/2024
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Jentadueto-H-C-2279-A31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2016-12-22 · EMA/867221/2016
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Jentadueto (metformin) : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-22
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Jentadueto : EPAR - Summary for the public
overview · 2016-07-21 · EMA/383982/2012
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Jentadueto (linagliptin / metformin) : EPAR - Scientific Conclusion
scientific-conclusion · 2016-04-15 · EMA/CHMP/174086/2016
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Jentadueto-H-C-2279-II-12 : EPAR - Assessment Report - Variation
variation-report · 2014-07-14 · EMA/CHMP/758426/2013
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Jentadueto : EPAR - Public assessment report
assessment-report · 2012-08-16
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。