欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0682/001
药品名称
Fluconazol "Nycomed"
活性成分
fluconazole 2.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Nycomed Danmark ApS Langebjerg 1 4000 Roskilde Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2004/10/10
最近更新日期
2012/12/31
药物ATC编码
J02AC01 fluconazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
1 3 1 Package leaflet core ENG Fluconazol Capsules
Date of last change:2024/09/06
Final Product Information
|
1 3 1 Summary of product Characteristics core ENG Fluconazol capsules
Date of last change:2024/09/06
Final Product Information
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1 3 1 Summary of product Characteristics core ENG Fluconazol infusion _2_
Date of last change:2024/09/06
Final PL
|
Approved PIL solution for infusion clean
Date of last change:2024/09/06
Final PL
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Approved PIL solution for infusion Track_Changes
Date of last change:2024/09/06
Final SPC
|
Approved SmPC capsules
Date of last change:2024/09/06
Final SPC
|
Approved SmPC capsules clean
Date of last change:2024/09/06
Final SPC
|
Approved SmPC solution for infusion
Date of last change:2024/09/06
Final SPC
|
Approved SmPC solution for infusion clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase