欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0631/003
药品名称
Etform SR
活性成分
metformin hydrochloride 1.0 g
剂型
Prolonged-release tablet
上市许可持有人
Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
参考成员国 - 产品名称
Poland (PL)
Etform SR
互认成员国 - 产品名称
Bulgaria (BG)
Meglucon XR
许可日期
2020/08/12
最近更新日期
2024/09/05
药物ATC编码
A10BA02 metformin
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
common_outer
Date of last change:2024/09/06
Final Product Information
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase