欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1218/004
药品名称
Pramipexol Synthon 0,7 mg Tabletten
活性成分
pramipexole dihydrochloride 1.0 mg
剂型
Tablet
上市许可持有人
Synthon B.V. Microweg 22 NL- 6545 CM Nijmegen Netherlands
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Spain (ES)
许可日期
2008/11/21
最近更新日期
2020/06/22
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 Labelling
|
common-fianl-labop-1218-V009G
Date of last change:2018/08/30
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 PL
|
DE1218+1434_Pramipexol_PL_20131122_renewal
Date of last change:2013/11/22
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase