欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2199/001
药品名称
Anastrella
活性成分
ethinyl estradiol 30.0 µg
Levonorgestrel 150.0 µg
剂型
Film-coated tablet
上市许可持有人
Orifarm Generics A/S
参考成员国 - 产品名称
Denmark (DK)
Anastrella
互认成员国 - 产品名称
Sweden (SE)
许可日期
2013/11/05
最近更新日期
2024/11/25
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 PL
|
Anastrella 28 FCT 20200309 PIL ENG A6239 LISAB_clean
Date of last change:2024/09/06
Final SPC
|
Anastrella 28 SPC common clean
Date of last change:2024/09/06
Final PL
|
Anastrella FCT 20200309 PIL ENG A6239 LISAB_clean
Date of last change:2024/09/06
Final Product Information
|
Anastrella SPC common clean
Date of last change:2024/09/06
Final Labelling
|
Anastrella_FCT_20170928_LAB_EN_A5265_VBE_CLEAN
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific discussion Anastrella_Anastrella28 DKH2199_001_002_DC
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase