法规知识库 · EMA 集中审评
Jardiance
empagliflozin · EMEA/H/C/002677 · 已授权
获批上市许可
2014-05-22
欧委会决定日
2026-03-24
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
23
官方索引 23
EPAR / 审评
21
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BK03
治疗领域：Diabetes Mellitus, Type 2;Heart Failure;Renal Insufficiency, Chronic
药理分类：Drugs used in diabetes
修订号：33 · 最新影响 PI 的程序：VR/0000333055
适应症（原文）：Type 2 diabetes mellitus Jardiance is indicated in adults and children aged 10 years and above 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 diabetes For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Jardiance is indicated in adults for the treatment of chronic kidney disease.
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。
2026-03-24 · 欧委会决定
2014-05-22 · 获批上市许可
2014-03-20 · 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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Jardiance : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-24
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Jardiance-H-C-PSUSA-00010388-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-06-25
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Jardiance : EPAR - Risk Management Plan
rmp · 2025-06-25
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Jardiance : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-25
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Jardiance-H-C-002677-II-0076- : EPAR - Assessment report - variation
variation-report · 2024-02-07 · EMA/542987/2023
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Jardiance : EPAR - Risk-management-plan summary
rmp-summary · 2024-02-07
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Jardiance : EPAR - Summary for the public
overview · 2024-01-29 · EMA/193010/2022
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Jardiance-H-C-002677-0074 : EPAR - Assessment report - variation
variation-report · 2023-09-04 · EMA/CHMP/137741/2014
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Jardiance-H-C-002677-II-0060 : EPAR - Assessment report - Variation
variation-report · 2022-03-30 · EMA/102340/2022
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Jardiance-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/193077/2022
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Jardiance-H-C-002677-II-0055 : EPAR - Assessment report - Variation
variation-report · 2021-07-23 · EMA/CHMP/275072/2021
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Jardiance-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/19602/2018
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Jardiance-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/493907/2017
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Jardiance-H-A20-1442-C-2677-0023 : EPAR - Assessment Report - Article 20
variation-report · 2017-07-05 · EMA/PRAC/637349/2016
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Jardiance-H-A20-1442-C-2677-0023 : EPAR - Scientific Conclusion - Article 20
scientific-conclusion · 2017-07-05
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Jardiance-H-C-2677-II-0014 : EPAR - Assessment Report
variation-report · 2017-03-30 · EMA/11728/2017
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Jardiance-H-C-2677-P46-0007 : EPAR - Assessment Report
variation-report · 2017-02-01 · EMA/70001/2017
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Jardiance-H-C-PSUSA-00010388-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
scientific-conclusion · 2016-09-23 · EMA/342499/2016
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Jardiance-H-C-2677-A20-1419-0007 : EPAR - Assessment Report - Article 20
variation-report · 2016-05-19 · EMA/PRAC/50218/2016
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Jardiance : EPAR - Scientific Conclusion
scientific-conclusion · 2016-05-19
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Jardiance : EPAR - Public assessment report
assessment-report · 2014-06-16 · EMA/CHMP/137741/2014
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。