欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2001/001
药品名称
Fampridine STADA
活性成分
Fampridine 10.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Stada Arzneimittel AG Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Spain (ES)
Finland (FI)
Czechia (CZ)
Fampridin STADA
Slovenia (SI)
Netherlands (NL)
Germany (DE)
Fampridin AL 10 mg Retardtabletten
Denmark (DK)
Greece (GR)
Norway (NO)
Luxembourg (LU)
Iceland (IS)
Austria (AT)
France (FR)
许可日期
2022/03/02
最近更新日期
2024/11/05
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 PL
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_2001_01_DC
Date of last change:2024/09/06
PubAR Summary
|
SE_H_2001_01_DC_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase