欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1218/005
药品名称
Pramipexol Synthon 1,1 mg Tabletten
活性成分
pramipexole dihydrochloride 1.5 mg
剂型
Tablet
上市许可持有人
Synthon BV Microweg 22 6545 CM Nijmegen Netherlands
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
许可日期
2008/11/21
最近更新日期
2019/01/22
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-fianl-spc-1218-V009G
Date of last change:2018/08/30
Final Product Information
|
common-fianl-pl-1218-V009G
Date of last change:2018/08/30
Final Labelling
|
common-fianl-labop-1218-V009G
Date of last change:2018/08/30
Final PL
|
common final PIL 1218
Date of last change:2015/07/09
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase