欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0345/004
药品名称
Flucobeta
活性成分
fluconazole 200.0 mg
剂型
Capsule, hard
上市许可持有人
TEVA Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands
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
2018/08/28
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 Labelling
|
Fluconazole capsules-DK_H_344-345-347_01-04-OuP-28.03.17 - Clean
Date of last change:2017/06/02
Final SPC
|
Fluconazole capsules-DK_H_344-345-347_01-04-SmPC-28.03.17 - Clean
Date of last change:2017/06/02
Final PL
|
Final PL, Clean - Fluconazole capsules-DK_H_345_01-04_IB_19
Date of last change:2016/04/14
市场状态
Withdrawn(注:已撤市)
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