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 SPC
|
clean 1_3_1 spc_label_pl _ common_spc _ 2_601
Date of last change:2024/09/06
Final Product Information
|
common_final_labop_1714_V021G
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_1714_V021G
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_1714_V021G
Date of last change:2024/09/06
PubAR
|
PAREN_DE1713_1719_Pramipexol_Sandoz_20100921_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase