欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1855/001
药品名称
Rigevidon 28
活性成分
ethinylestradiol 30.0 µg
levonorgestrel 150.0 µg
剂型
Coated tablet
上市许可持有人
Gedeon Richter Plc. 1103 Budapest, Gyömroi út 19-21 Hungary
参考成员国 - 产品名称
Denmark (DK)
Rigevidon 28
互认成员国 - 产品名称
Sweden (SE)
Midiole
Finland (FI)
许可日期
2011/07/11
最近更新日期
2023/06/23
药物ATC编码
G03AA07 levonorgestrel and ethinylestradiol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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 Labelling
|
common_labeling_clean
Date of last change:2024/09/06
Final PL
|
DK_H_1855_001_IB_015 _ Rigevidon PIL common clean
Date of last change:2024/09/06
Final SPC
|
DK_H_1855_001_IB_015 _ Rigevidon SPC common clean
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific discussion Rigevidon 28 DKH_1855_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