欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1360/004
药品名称
Pramipexol Teva Pharma
活性成分
PRAMIPEXOLE DIHYDROCHLORIDE monohydrate 1.57 mg
剂型
Prolonged-release tablet
上市许可持有人
Teva Sweden AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Hungary (HU)
PRAMIPEXOL TEVA 1,57 mg retard tabletta
Denmark (DK)
Netherlands (NL)
Pramipexol retard Teva 1,57 mg, tabletten met verlengde afgifte
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Pramipexol ratiopharm 1,57 mg Retardtabletten
许可日期
2014/12/01
最近更新日期
2024/10/24
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 PL
|
SE_H_1360_004_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1360_004_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1360_004_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1360_004_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase