欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1862/001
药品名称
Celia
活性成分
ethinylestradiol 15.0 µg
gestodene 60.0 µg
剂型
Film-coated tablet
上市许可持有人
Gedeon Richter Plc. 1103 Budapest Hungary
参考成员国 - 产品名称
Denmark (DK)
Celia
互认成员国 - 产品名称
Austria (AT)
Varianta 15 Mikrogramm/60 Mikrogramm Filmtabletten
许可日期
2011/02/23
最近更新日期
2023/03/09
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
|
1862 _V020_V021 common_pil_clean
Date of last change:2024/09/06
Final SPC
|
1862 _V020_V021 common_spc_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer
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
PubAR
|
Final PAR Celia DKH_1862_001_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase