欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1433/003
药品名称
Olmesartan Hexal
活性成分
Olmesartan medoxomil 40.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz Farmacêutica, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
许可日期
2016/02/24
最近更新日期
2024/10/19
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 PL
|
PL_PT_H_1433_003_IB_020
Date of last change:2024/10/19
Final SPC
|
SmPC_PT_H_1433_003_IB_020
Date of last change:2024/10/19
Final Product Information
|
1_3_1 spc_label_pl _ common_outer _ 2_699
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_pl _ 6_866
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_SPC _ 2_605
Date of last change:2024/09/06
PubAR
|
598422_598423_598424_20160630_PAR_IRS
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase