欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1088/001
药品名称
Clarifast
活性成分
Fexofenadine hydrochloride 120.0 mg
剂型
Film-coated tablet
上市许可持有人
Chanelle Medical Unlimited Company Loughrea, Co. Galway Ireland
参考成员国 - 产品名称
Denmark (DK)
Clarifast
互认成员国 - 产品名称
Ireland (IE)
Poland (PL)
Telfexo 120 mg
许可日期
2007/07/18
最近更新日期
2024/09/12
药物ATC编码
R06AX26 fexofenadine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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:2024/09/06
Final SPC
|
Common SmPC 180mg_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_proposed_120 mg_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_proposed_180 mg_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase