欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1421/004
药品名称
Olmesartan + Hidroclorotiazida Aurovitas
活性成分
hydrochlorothiazide 25.0 mg
olmesartan medoxomil 40.0 mg
剂型
Film-coated tablet
上市许可持有人
Aurovitas Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
许可日期
2015/11/18
最近更新日期
2024/07/30
药物ATC编码
C09CA08 olmesartan medoxomil
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
PubAR Summary
|
593722_593723_593724_20160106_PAR_ACM
Date of last change:2024/09/06
Final Labelling
|
Labelling_Clean
Date of last change:2024/09/06
Final PL
|
PIL_ 20_12_5 _ 20_25 mg_Clean
Date of last change:2024/09/06
Final PL
|
PIL_40_12_5 _ 40_25 mg_Clean
Date of last change:2024/09/06
Final SPC
|
SPC_20_12_5 _ 20_25 mg_Clean
Date of last change:2024/09/06
Final SPC
|
SPC_40_12_5 _ 40_25 mg_Clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase