欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1714/003
药品名称
Pramipexol Hexal 0,35 mg Tabletten
活性成分
pramipexole dihydrochloride 0.5 mg
剂型
Tablet
上市许可持有人
HEXAL AG Industriestrasse 25 83607 Holzkirchen Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
许可日期
2009/07/15
最近更新日期
2017/06/21
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 Product Information
|
common-final-labop-1714-V021G
Date of last change:2017/06/21
Final Product Information
|
common-final-pl-1714-V021G
Date of last change:2017/06/21
Final Product Information
|
common-final-spc-1714-V021G
Date of last change:2017/06/21
PAR
|
PAREN-DE1713-1719-Pramipexol-Sandoz-20100921-final
Date of last change:2013/06/10
Final SPC
|
clean 1.3.1 spc-label-pl - common-spc - 2,601
Date of last change:2013/01/10
市场状态
Positive
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