欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0598/001
药品名称
Fosinopril + Hidroclorotiazida Aurobindo
活性成分
fosinopril sodium salt 20.0 mg
hydrochlorothiazide 12.5 mg
剂型
Tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unipessoal Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
France (FR)
Spain (ES)
Italy (IT)
Malta (MT)
Fosinopril + Hydrochlorothiazide Aurobindo 20mg + 12.5mg tablets
许可日期
2012/01/18
最近更新日期
2023/08/07
药物ATC编码
C09BA09 fosinopril and diuretics
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
|
common-outer
Date of last change:2014/03/27
Final PL
|
common-pl
Date of last change:2014/03/27
Final SPC
|
Clean_Fosinopril+HCTZ Aurobindo_SPC_05-01-2012
Date of last change:2012/01/20
市场状态
Positive
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