法规知识库 · EMA 集中审评
Ebymect
dapagliflozin propanediol monohydrate;metformin hydrochloride · EMEA/H/C/004162 · 已授权
获批上市许可
2015-11-15
欧委会决定日
2026-03-12
持有人 / 申请人
AstraZeneca AB
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BD15
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：25 · 最新影响 PI 的程序：VR/0000310736
适应症（原文）：Type 2 diabetes mellitus For the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. Type 1 diabetes mellitus Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ? 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
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。
2026-03-12 · 欧委会决定
2015-11-15 · 获批上市许可
2015-09-23 · 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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Ebymect : EPAR - Risk-management-plan
rmp · 2026-06-05
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Ebymect : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-13
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Ebymect : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-23
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Ebymect-H-C-4162-WS-1539 : EPAR - Assessment report - Variation
variation-report · 2019-08-28 · EMA/476671/2019
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Ebymect : EPAR - Medicine overview
overview · 2019-08-28 · EMA/467741/2019
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Ebymect-H-A20-1442-C-4162-0013 : EPAR - Assessment Report - Article 20
variation-report · 2017-07-05 · EMA/PRAC/637349/2016
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Ebymect-H-A20-1442-C-4162-0013 : EPAR - Scientific Conclusion - Article 20
scientific-conclusion · 2017-07-05
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Ebymect-H-C-4162-A31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2016-12-21 · EMA/867221/2016
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Ebymect : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-21
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Ebymect : EPAR - Public assessment report
assessment-report · 2015-11-23 · EMA/679419/2015
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。