欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0700/001
药品名称
Feminil Mite
活性成分
cyproterone acetate 2.0 mg
ethinylestradiol 35.0 µg
剂型
Tablet
上市许可持有人
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odese SØ 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
2005/06/16
最近更新日期
2020/01/08
药物ATC编码
G03HB01 cyproterone and estrogen
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
_Core_ PIL Feminil mite 1557939 20181214 TC _ Clean
Date of last change:2024/09/06
Final SPC
|
_Core_ SmPC Feminil mite 1557939 20181207 TC _ Clean
Date of last change:2024/09/06
Final Labelling
|
Updated _ final Labelling _ Clean
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
©2006-2025
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European Union HMA Authorisation of Medicines DataBase