欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1087/001
药品名称
Alterfast
活性成分
fexofenadine hydrochloride 120.0 mg
剂型
Film-coated tablet
上市许可持有人
Chanelle Medical Ltd. Loughrea, Co. Galway Ireland
参考成员国 - 产品名称
Denmark (DK)
Alterfast
互认成员国 - 产品名称
France (FR)
Italy (IT)
Bulgaria (BG)
Ewofex
Czechia (CZ)
Ewofex 120 mg potahovane tablety
许可日期
2007/07/18
最近更新日期
2023/11/17
药物ATC编码
R06AX26 fexofenadine
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
|
Common PIL_clean
Date of last change:2023/09/27
Final SPC
|
Common 180mg SmPC_clean
Date of last change:2023/09/27
Final Labelling
|
common-outer-120mg-proposed-clean
Date of last change:2018/08/27
Final Labelling
|
common-outer-180mg-proposed-clean
Date of last change:2018/08/27
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase