欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0938/001
药品名称
Aldan Combo
活性成分
Amlodipine 5.0 mg
Perindopril arginine 5.0 mg
剂型
Tablet
上市许可持有人
Polfarmex S.A. ul. Jozefow 9 99-300 Kutno Poland
参考成员国 - 产品名称
Poland (PL)
Aldan Combo
互认成员国 - 产品名称
Czechia (CZ)
Ikarium Combo
许可日期
2024/11/18
最近更新日期
2024/11/21
药物ATC编码
C09BB04 perindopril and amlodipine
申请类型
TypeLevel1:
Known Active Substance
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
|
Summary PAR PL_H_0938_001_003_DC
Date of last change:2025/01/13
PubAR
|
PAR PL_H_0938_001_003_DC
Date of last change:2025/01/13
Final Labelling
|
common labelling
Date of last change:2024/11/21
Final SPC
|
common_smpc
Date of last change:2024/11/21
Final PL
|
common_pl
Date of last change:2024/11/21
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase