欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0347/003
药品名称
Flucozeta
活性成分
fluconazole 150.0 mg
剂型
Capsule, hard
上市许可持有人
AbZ Pharma GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2002/09/16
最近更新日期
2020/08/12
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 PL
|
Final PL_ Clean _ Fluconazole capsules_DK_H_347_01_03_IB_22
Date of last change:2024/09/06
Final Labelling
|
Fluconazole capsules_DK_H_344_345_347_01_04_OuP_28_03_17 _ Clean
Date of last change:2024/09/06
Final SPC
|
Fluconazole capsules_DK_H_344_345_347_01_04_SmPC_28_03_17 _ Clean
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase