欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2540/001
药品名称
Fampridina Generis
活性成分
fampridine 10.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Generis - Farmacêutica S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Germany (DE)
Netherlands (NL)
Fampridine Aurobindo 10mg, tabletten met verlengde afgifte
France (FR)
许可日期
2022/05/11
最近更新日期
2022/05/11
药物ATC编码
N07XX07 fampridine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
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 Product Information
|
Fampridine PR Tablets_LAB_clean
Date of last change:2024/09/06
Final Product Information
|
Fampridine PR Tablets_PIL_clean
Date of last change:2024/09/06
Final Product Information
|
Fampridine PR Tablets_SmPC_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase