欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2357/001
药品名称
Frivelle
活性成分
levonorgestrel 1.5 mg
剂型
Tablet
上市许可持有人
Orifarm Generics A/S Energivej 15, POB 69 5260 Odense S Denmark
参考成员国 - 产品名称
Denmark (DK)
Frivelle
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Frivelle
许可日期
2014/12/03
最近更新日期
2024/05/21
药物ATC编码
G03AD01 levonorgestrel
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
common_interpack
Date of last change:2024/09/06
Final PL
|
Frivelle TAB 20181212 PIL ENG A5762 DOSRJ _ Clean
Date of last change:2024/09/06
Final SPC
|
Frivelle TAB 20181212 SPC ENG A5762 DOSRJ _ Clean
Date of last change:2024/09/06
Final Product Information
|
Frivelle TAB 20190909 PIL ENG A5920 DOSRJ TC _ no RMS comments
Date of last change:2024/09/06
Final Product Information
|
Frivelle TAB 20190909 SPC ENG A5920 DOSRJ TC_ no RMS comments
Date of last change:2024/09/06
PubAR
|
PAR Frivelle DK_2357_001_DC
Date of last change:2024/09/06
PubAR
|
Summary PAR Frivelle DK_2357_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