欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0388/001
药品名称
Fluconazole Elvim
活性成分
fluconazole 2.0 mg/ml
剂型
Solution for infusion
上市许可持有人
SIA Elvim Kurzemes Prospekts 3g Riga 1067 Latvia
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Latvia (LV)
Lithuania (LT)
Fluconazole ELVIM 2 mg/ml infuzinis tirpalas
许可日期
2024/03/14
最近更新日期
2024/03/14
药物ATC编码
J02AC01 fluconazole
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
PubAR
|
EE_388_Fluconazole_Elvim_PAR
Date of last change:2024/09/06
Final Labelling
|
EE_H_388_Final_Lab
Date of last change:2024/09/06
Final PL
|
EE_H_388_Final_PL
Date of last change:2024/09/06
Final SPC
|
EE_H_388_Final_SmpC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase