欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0162/001
药品名称
Pramipexolo Pensa
活性成分
pramipexole 180.0 µg
剂型
Tablet
上市许可持有人
Towa Pharmaceutical S.p.A. via Enrico Tazzoli n. 6 20154 Milan Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Spain (ES)
许可日期
2009/05/21
最近更新日期
2023/12/21
药物ATC编码
N04BC05 pramipexole
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 PL
|
Common PL Pramipexolo Pensa (clean)
Date of last change:2020/06/12
Final SPC
|
Common SPC Pramipexolo Pensa (clean)
Date of last change:2020/06/12
Final Labelling
|
common-label-pramipexole-tr
Date of last change:2017/08/14
市场状态
Positive
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