欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0440/004
药品名称
Fluconazol "Hexal"
活性成分
fluconazole 200.0 mg
剂型
Capsule, hard
上市许可持有人
HEXAL A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Sweden (SE)
许可日期
2003/06/01
最近更新日期
2023/10/25
药物ATC编码
J02AC01 fluconazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
DK_H_0440_001_004_WS_1414_ FLUCONAZOLE_FINAL_SmPC_cv
Date of last change:2023/10/25
Final PL
|
DK_H_0440_001_004_WS_1414_ FLUCONAZOLE_FINAL_PI_cv
Date of last change:2023/10/25
Final Labelling
|
1.3.1 spc-label-pl - common-outer -cl
Date of last change:2021/10/15
Final Product Information
|
common-spc- clean
Date of last change:2019/02/14
Final Product Information
|
common-outer - clean
Date of last change:2019/02/14
Final Product Information
|
common-pl - clean
Date of last change:2019/02/14
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase