欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1899/001
药品名称
Finail
活性成分
amorolfine hydrochloride 5.0 %
剂型
Medicated nail laquer
上市许可持有人
Orifarm Generics A/S Energivej 15, POB 69 5260 Odense Denmark
参考成员国 - 产品名称
Denmark (DK)
Finail
互认成员国 - 产品名称
Sweden (SE)
Finail
许可日期
2011/02/17
最近更新日期
2023/07/21
药物ATC编码
D01AE16 amorolfine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final PL
|
Finail MNL 20150422 PIL RENEWAL JETVP ENG_CLEAN version includes all changes
Date of last change:2024/09/06
Final SPC
|
Finail MNL 20150422 SPC RENEWAL JETVP ENG_CLEAN version includes all changes
Date of last change:2024/09/06
Final Labelling
|
Finail MNL 20170728 LAB BOX_BOTTLE ENG A5161 LLM
Date of last change:2024/09/06
市场状态
Positive
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