欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0660/002
药品名称
Pramipexol Aurobindo
活性成分
pramipexole dihydrochloride 0.09 mg
剂型
Tablet
上市许可持有人
Aurobindo Pharma (Malta) Ltd.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Denmark (DK)
Sweden (SE)
Germany (DE)
Pramipexol Aurobindo 0,088 mg Tabletten
France (FR)
Italy (IT)
Romania (RO)
PRAMIPEXOL AUROBINDO 0,18 mg comprimate
Malta (MT)
Pramipexole Aurobindo 0.088mg Tablets
Spain (ES)
许可日期
2012/04/03
最近更新日期
2024/06/28
药物ATC编码
N04BC05 pramipexole
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
|
common_pl_final
Date of last change:2024/06/28
Final SPC
|
common_spc_final
Date of last change:2024/06/28
Final Product Information
|
Clean_Pramipexole Aurobindo_SPC
Date of last change:2014/06/30
Final Product Information
|
Clean_Pramipexole Aurobindo_Lab
Date of last change:2014/06/30
Final Product Information
|
Clean_Pramipexole Aurobindo_PIL
Date of last change:2014/06/30
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase