欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1319/002
药品名称
Glepark
活性成分
Pramipexole dihydrochloride 0.25 mg
剂型
Tablet
上市许可持有人
Glenmark Arzneimittel GmbH Industriestrasse 31 82194 Grobenzell Germany
参考成员国 - 产品名称
Netherlands (NL)
Glepark
互认成员国 - 产品名称
Germany (DE)
Denmark (DK)
Greece (GR)
Czechia (CZ)
Slovakia (SK)
许可日期
2009/02/08
最近更新日期
2024/11/12
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 PL
|
Common PL
Date of last change:2024/09/06
Final SPC
|
Common SmPC
Date of last change:2024/09/06
Final Labelling
|
final day 210 labelling_pramipexole
Date of last change:2024/09/06
PubAR
|
PAR_1319_DC_pramipexole_2 June 2010
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase