欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1209/002
药品名称
Ronipan
活性成分
ropinirole hydrochloride 0.5 mg
剂型
Film-coated tablet
上市许可持有人
Ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2008/07/09
最近更新日期
2017/09/04
药物ATC编码
N04BC04 ropinirole
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
|
DK_H_1209_001_006_II_016_Ronipan_Final_PIL_CL
Date of last change:2024/09/06
Final SPC
|
DK_H_1209_001_006_II_016_Ronipan_Final_SmPC_CL
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase