欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1860/001
药品名称
Vendiol
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)
Vendiol
互认成员国 - 产品名称
Norway (NO)
Poland (PL)
Vines
Hungary (HU)
SOLDANELLE 60 mikrogramm/15 mikrogramm filmtabletta
Czechia (CZ)
Vendiol Potahované tablety
Slovakia (SK)
Vendiol filmom obalené tablety
许可日期
2011/02/23
最近更新日期
2024/11/29
药物ATC编码
G03AA10 gestodene 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
|
1860 _ common_pl_clean
Date of last change:2024/09/06
Final SPC
|
1860 _V023_V024 common_spc_clean
Date of last change:2024/09/06
Final Product Information
|
1860 V023_V024 common_pil_clean
Date of last change:2024/09/06
Final Labelling
|
common_other_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Vendiol DKH_1830_001_DC
Date of last change:2024/09/06
PubAR
|
PAR_module_6_update_scientific discussion
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase