欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0566/001
药品名称
Amlodipin "Actavis"
活性成分
Amlodipine mesilate 5.0 mg
剂型
Tablet
上市许可持有人
Actavis Group PTC ehf. Dalshraun 1 220 Hafnarfjörður, Iceland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2003/12/17
最近更新日期
2024/10/01
药物ATC编码
C08CA01 amlodipine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Article 4.8(a)(iii), second paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Amlodipine_DK_H_0566_001_002_OuP_ImP
Date of last change:2024/09/06
Final PL
|
Amlodipine_DK_H_0566_001_002_PIL_ clean
Date of last change:2024/09/06
Final SPC
|
Amlodipine_DK_H_0566_001_002_SmPC_clean
Date of last change:2024/09/06
Final Product Information
|
PI_Amlodipine_DK_H_0566_V73_Final PI_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase