欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1545/001
药品名称
Metformine HCl/Glibenclamide Sandoz 500/2,5 mg
活性成分
glibenclamide 2.5 mg
metformin hydrochloride 500.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz B.V., NL
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
许可日期
2009/10/19
最近更新日期
2019/09/12
药物ATC编码
A10BD02 metformin and sulfonylureas
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Product Information
|
1545_common_outer
Date of last change:2024/09/06
Final Product Information
|
1545_common_spc
Date of last change:2024/09/06
Final Product Information
|
1545_ommon_pl
Date of last change:2024/09/06
Final PL
|
Common leaflet 1545 _ cl _ 020213
Date of last change:2024/09/06
Final SPC
|
Common SmPC 1545 clean _ 020213
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase