法规知识库 · EMA 集中审评
Synjardy
empagliflozin;metformin · EMEA/H/C/003770 · 已授权
获批上市许可
2015-05-27
欧委会决定日
2026-05-21
持有人 / 申请人
Boehringer Ingelheim
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
18
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BD20
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：33 · 最新影响 PI 的程序：VR/0000332811
适应症（原文）：Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: in patients insufficiently controlled on their maximally tolerated dose of metformin alone in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products in patients already being treated with the combination of empagliflozin and metformin as separate tablets. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.
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。
2026-05-21 · 欧委会决定
2015-05-27 · 获批上市许可
2015-03-26 · 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
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Synjardy : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-06
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Synjardy-H-C-PSUSA-00010388-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-07-01
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Synjardy : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-01
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Synjardy : EPAR - Risk management plan
rmp-summary · 2025-07-01
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Synjardy : EPAR - Medicine overview
overview · 2025-01-15 · EMA/447728/2024
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Synjardy-H-C-003770-II-0078 : EPAR - Assessment report - Variation
variation-report · 2024-11-25 · EMA/464344/2024
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Synjardy-H-C-PSUSA-00010388-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-03-30 · EMA/189983/2022
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Synjardy-H-C-PSUSA-00010388-201704 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-01-11 · EMA/19599/2018
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Synjardy-H-C-PSUSA-00010388-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-08-03 · EMA/493961/2017
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Synjardy-H-A20-1442-C-3770-0022 : EPAR - Scientific Conclusion - Article 20
scientific-conclusion · 2017-07-05
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Synjardy-H-A20-1442-C-3770-0022 : EPAR - Assessment Report - Article 20
variation-report · 2017-07-05 · EMA/PRAC/637349/2016
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Synjardy-H-C-3770-II-0015 : EPAR - Assessment Report - Variation
variation-report · 2017-05-10 · EMA/173251/2017
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Synjardy-H-C-3770-A-31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2017-01-09 · EMA/867221/2016
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Synjardy : EPAR - Scientific Conclusion
scientific-conclusion · 2017-01-09
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Synjardy-H-C-PSUSA-00010388-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
scientific-conclusion · 2016-07-20 · EMA/342499/2016
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Synjardy-H-C-3770-A20-1419-0001 : EPAR - Assessment Report - Article 20
variation-report · 2016-05-19 · EMA/PRAC/50218/2016
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Synjardy : EPAR - Scientific Conclusion
scientific-conclusion · 2016-05-19
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Synjardy : EPAR - Public assessment report
assessment-report · 2015-06-12 · EMA/238334/2015
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。