欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1429/001
药品名称
Nebivolol "Portfarma"
活性成分
nebivolol hydrochloride 5.0 mg
剂型
Tablet
上市许可持有人
Portfarma ehf. Borgartúni 26 105 Reykjavik Iceand
参考成员国 - 产品名称
Denmark (DK)
Nebivolol "Portfarma"
互认成员国 - 产品名称
许可日期
2008/11/13
最近更新日期
2016/06/03
药物ATC编码
C07AB12 nebivolol
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 Product Information
|
Common PI_clean
Date of last change:2024/09/06
PubAR
|
Module 2 SmPC Nebivolol Portfarma
Date of last change:2024/09/06
PubAR
|
Module 3 PIL and Module 4 Labelling Nebivolol Portfarma
Date of last change:2024/09/06
Final PL
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PIL DK_H_1429_001_E_01
Date of last change:2024/09/06
Final SPC
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SmPC DK_H_1429_001_E_01
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase