欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1258/003
药品名称
Pramipexol ratiopharm 0,35 mg Tabletten
活性成分
pramipexole dihydrochloride 0.5 mg
剂型
Tablet
上市许可持有人
ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm 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
2009/12/17
最近更新日期
2024/03/19
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
|
final_common_spc_DE_H_1258_001_004_IA_024
Date of last change:2024/03/19
Final PL
|
final_common_pl_DE_H_1258_001_004_IA_024
Date of last change:2024/03/19
Final Labelling
|
DE1258_Pramipexole tablets-ImP_20141016_renewal
Date of last change:2014/10/16
Final Labelling
|
DE1258_Pramipexole tablets-OuP_20141016_renewal
Date of last change:2014/10/16
PAR
|
PAREN-DE1258-Pramipexol ratiopharm-20100319-final
Date of last change:2013/05/24
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase