欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2022/001
药品名称
Zulfija
活性成分
ethinyl estradiol 20.0 µg
gestodene 75.0 µg
剂型
Coated tablet
上市许可持有人
Gedeon Richter Plc. Budapest Hungary
参考成员国 - 产品名称
Denmark (DK)
Zulfija
互认成员国 - 产品名称
许可日期
2012/01/26
最近更新日期
2022/10/24
药物ATC编码
G03AA10 gestodene and ethinylestradiol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
2022_001 _ common_pl_clean
Date of last change:2024/09/06
Final SPC
|
2022_001 _ common_spc_clean
Date of last change:2024/09/06
Final PL
|
2022_002 _ common_pl_clean
Date of last change:2024/09/06
Final SPC
|
2022_002 _ common_spc_clean
Date of last change:2024/09/06
Final Product Information
|
common_pl_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_clean
Date of last change:2024/09/06
Final Labelling
|
DK2021_22 Final labelling for both combinations
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific dicsussion Zulfija DKH2022_001_002_DC
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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