欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0343/001
药品名称
Olmesartan Medoxomil Teva
活性成分
olmesartan medoxomil 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Swensweg 5 Haarlem 2031 GA Netherlands
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Germany (DE)
Olmesartan-AbZ 10 mg Filmtabletten
Belgium (BE)
Olmesartan Teva 10 mg filmomhulde tabletten
Netherlands (NL)
Portugal (PT)
Italy (IT)
Bulgaria (BG)
Olmesta
许可日期
2022/04/13
最近更新日期
2023/08/17
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
Final Labelling
|
1_3_1 label_immediate blisters _ clean
Date of last change:2024/09/06
Final PL
|
1_3_1 pil _ clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 smpc _ clean
Date of last change:2024/09/06
PubAR
|
EE_H_343_PAR
Date of last change:2024/09/06
Final Labelling
|
label_outer packaging
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase