法规知识库 · EMA 集中审评
Komboglyze
metformin hydrochloride;saxagliptin hydrochloride · EMEA/H/C/002059 · 已授权
获批上市许可
2011-11-24
欧委会决定日
2025-05-08
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
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BD10
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes;Combinations of oral blood glucose lowering drugs
修订号：23 · 最新影响 PI 的程序：VR/0000258017
适应症（原文）：Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.
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。
2025-05-08 · 欧委会决定
2011-11-24 · 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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Komboglyze : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-23
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Komboglyze : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-04-09
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Komboglyze : EPAR - Risk-management-plan summary
rmp-summary · 2022-09-22
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Komboglyze-H-C-2059-P46-0017 : EPAR - Assessment Report
variation-report · 2018-01-09 · EMA/10275/2018
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Komboglyze-H-C-2059-WS-1078 : EPAR - Assessment report - Variation
variation-report · 2017-08-02 · EMA/CHMP/291920/2017
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Komboglyze : EPAR - Summary for the public
overview · 2017-08-02 · EMA/806986/2011
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Komboglyze-H-C-2059-20-A-31-1432 : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-21
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Komboglyze-H-C-A-31-1432 : EPAR - Assessment Report - Article 31
variation-report · 2016-12-21 · EMA/867221/2016
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Komboglyze : EPAR - Scientific conclusions and grounds recommending the variation
scientific-conclusion · 2015-09-10
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Komboglyze-H-C-2059-WS-0295 : EPAR - Assessment report - Variation
variation-report · 2013-06-14 · EMA/302364/2013
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Komboglyze-H-C-2059-II-0004 : EPAR - Assessment Report - Variation
variation-report · 2013-02-08 · EMA/70628/2013
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Komboglyze : EPAR - Public assessment report
assessment-report · 2011-12-16
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。