欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0165/005
药品名称
Pramipexolo Zentiva
活性成分
pramipexole 1100.0 µg
剂型
Tablet
上市许可持有人
Zentiva Italia s.r.l., Via P. Paleocapa, 7 20121 Milano Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Germany (DE)
许可日期
2009/05/21
最近更新日期
2022/11/16
药物ATC编码
N04BC05 pramipexole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 SPC
|
Common combined SPC - PL - ET Pramipexolo Zentiva (clean)
Date of last change:2020/06/18
Final Product Information
|
Pramipexole_tablet_IT-H-165_EN_TXT_PRAC 171009 clean
Date of last change:2018/03/10
Final PL
|
Final PL
Date of last change:2012/01/17
Final Labelling
|
Final labelling
Date of last change:2011/12/02
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase