欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2736/001
药品名称
Metformin hydrochloride
活性成分
Metformin 500.0 mg
剂型
Coated tablet
上市许可持有人
IPCA - Produtos Farmacêuticos Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Metformin 500 mg Filmtabletten
许可日期
2022/10/13
最近更新日期
2024/11/30
药物ATC编码
A10BA02 metformin
申请类型
TypeLevel1:
Abridged
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
|
outerpack_500mg_bottle_cl
Date of last change:2024/11/30
Final PL
|
pil_cl
Date of last change:2024/11/30
Final SPC
|
spc_500mg_cl
Date of last change:2024/11/30
PubAR
|
PT_2736_PAR_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase