欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2005/001
药品名称
Arupsan
活性成分
ESLICARBAZEPINE ACETATE 200.0 mg
剂型
Tablet
上市许可持有人
Accord Healthcare B.V. Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Spain (ES)
Portugal (PT)
Czechia (CZ)
Arupsan
Croatia (HR)
Eslikarbazepinacetat Accord 200 mg tablete
Denmark (DK)
United Kingdom (Northern Ireland) (XI)
许可日期
2020/12/02
最近更新日期
2023/11/29
药物ATC编码
N03AF04 eslicarbazepine
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
PAR Summary
|
SE/H/2005/001_PAR Summary
Date of last change:2021/02/09
PAR
|
SE/H/2005/001_PAR
Date of last change:2021/02/09
Final PL
|
SE/H/2005/001_Final PL
Date of last change:2021/01/20
Final SPC
|
SE/H/2005/001_Final SPC
Date of last change:2021/01/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase