欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0381/002
药品名称
EPLERENONE ALAPIS 50 MG
活性成分
eplerenone 50.0 mg
剂型
Film-coated tablet
上市许可持有人
(AIA) Alapis S.A., Athens
参考成员国 - 产品名称
Czechia (CZ)
EPLERENONE ALAPIS 50 MG
互认成员国 - 产品名称
Greece (GR)
许可日期
2011/09/27
最近更新日期
2023/12/12
药物ATC编码
C03DA04 eplerenone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 SPC
|
CZ_H_0139_0380_0384_01_02_DC_Day 210_Labelling
Date of last change:2024/09/06
Final SPC
|
CZ_H_0139_0380_0384_01_02_DC_Day 210_PIL
Date of last change:2024/09/06
Final SPC
|
CZ_H_0139_0380_0384_01_02_DC_Day 210_SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase