欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1208/004
药品名称
Ropinirol-CT 2 mg Filmtabletten
活性成分
ropinirole hydrochloride 2.0 mg
剂型
Film-coated tablet
上市许可持有人
CT-Arzneimittel, Berlin, 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
2017/10/19
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_1208_001_004_II_020_Ropinirol_Teva_Pharma_Final_PIL_CL
Date of last change:2024/09/06
Final SPC
|
DK_H_1208_001_004_II_020_Ropinirol_Teva_Pharma_Final_SmPC_CL
Date of last change:2024/09/06
Final Labelling
|
Ropinirole_DK_H_1208_09_01_04_Labeling
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Withdrawn(注:已撤市)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