法规知识库 · EMA 集中审评
Forxiga
dapagliflozin propanediol monohydrate · EMEA/H/C/002322 · 已授权
获批上市许可
2012-11-11
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
22
官方索引 22
EPAR / 审评
19
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BK01
治疗领域：Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic
药理分类：Drugs used in diabetes
修订号：34 · 最新影响 PI 的程序：VR/0000310736
适应症（原文）：Type 2 diabetes mellitus Forxiga 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 type 2 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 Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Forxiga 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。
2026-03-12 · 欧委会决定
2012-11-11 · 获批上市许可
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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Forxiga : EPAR - Risk Management Plan
rmp · 2026-06-11
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Forxiga : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-12
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Forxiga : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-03-12
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Forxiga-H-C-PSUSA-00010029-202310 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-10-31 · EMA/505062/2024
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Forxiga : EPAR - Medicine overview
overview · 2023-03-06 · EMA/12370/2023
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Forxiga-H-C-WS-2299 : EPAR - Assessment report - Variation
variation-report · 2023-03-01 · EMA/954956/2022
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Forxiga-H-C-PSUSA-00010029-202110 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-discussion-variation · 2022-08-22 · EMA/700831/2022
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Forxiga : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2022-06-27 · EMA/CHMP/592350/2022
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Forxiga-H-C-WS-1952 : EPAR - Assessment report - Variation
variation-report · 2022-01-05 · EMA/622203/2021
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Forxiga-H-C-WS-1941 : EPAR - Assessment report - Variation
variation-report · 2021-09-02 · EMA/431093/2021
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Forxiga-H-C-2322-WS-1737: EPAR - Assessment report - Variation
variation-report · 2020-11-26 · EMA/574301/2020
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Forxiga-H-C-2322-WS-1539: EPAR - Assessment report - Variation
variation-report · 2019-08-28 · EMA/476671/2019
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Forxiga-H-C-PSUSA-00010029-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-07-27 · EMA/465597/2017
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Forxiga-H-A20-1442-C-2322-0029 : EPAR - Scientific Conclusion - Article 20
scientific-conclusion · 2017-07-05
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Forxiga-H-A20-1442-C-2322-0029 : EPAR - Assessment Report - Article 20
variation-report · 2017-07-05 · EMA/PRAC/637349/2016
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Forxiga : EPAR - Scientific Conclusion
scientific-conclusion · 2016-05-18
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Forxiga-H-C-2322-A20-1419-0021 : EPAR - Assessment Report - Article 20
variation-report · 2016-05-18 · EMA/PRAC/50218/2016
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Forxiga-H-C-2322-P46-016 : EPAR - Assessment report
variation-report · 2016-01-05 · EMA/CHMP/784877/2015
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Forxiga : EPAR - Public assessment report
assessment-report · 2012-12-07 · EMA/689976/2012
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。