法规知识库 · EMA 集中审评
Vokanamet
canagliflozin;metformin hydrochloride · EMEA/H/C/002656 · 已授权
获批上市许可
2014-04-23
欧委会决定日
2026-05-07
持有人 / 申请人
Janssen-Cilag International NV
终止日期字段
无
从产品到官方文件
文件记录
17
官方索引 17
EPAR / 审评
14
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BD16
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：VR/0000332854
适应症（原文）：Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients not adequately controlled on their maximally tolerated doses of metformin alone in patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control. in patients already being treated with the combination of canagliflozin and metformin as separate tablets 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.
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。
2026-05-07 · 欧委会决定
2014-04-23 · 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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Vokanamet : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-26
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Vokanamet : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-10
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Vokanamet : EPAR - Risk management plan
rmp · 2024-12-18
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Vokanamet-H-C-PSUSA-00010077-201903 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-02-18 · EMA/67311/2020
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Vokanamet-H-A20-1442-C-2656-0014 : EPAR - Assessment Report - Article 20
variation-report · 2017-07-05 · EMA/PRAC/637349/2016
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Vokanamet-H-A20-1442-C-2656-0014 : EPAR - Scientific Conclusion - Article 20
scientific-conclusion · 2017-07-05
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Vokanamet-H-C-2656-A-31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2016-12-21 · EMA/CHMP/539626/2016 Corr. 2
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Vokanamet-H-C-2656-A-31-1432 : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-21
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Vokanamet-H-C-2656-A20-1419-0007 : EPAR - Scientific Conclusion
scientific-conclusion · 2016-05-19
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Vokanamet-H-C-2656-A20-1419-0007 : EPAR - Assessment Report - Article 20
variation-report · 2016-05-19 · EMA/PRAC/50218/2016
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Vokanamet-H-C-PSUSA-00010077-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-01-29 · EMA/766817/2015
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Vokanamet-H-C-PSUSA-00010077-201411 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-09-29 · EMA/602251/2015
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Vokanamet : EPAR - Summary for the public
overview · 2014-05-15 · EMA/119828/2014
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Vokanamet : EPAR - Public assessment report
assessment-report · 2014-05-15 · EMA/179391/2014
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。