欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0799/001
药品名称
Melitta
活性成分
ethinylestradiol 30.0 µg
gestodene 75.0 µg
剂型
Coated tablet
上市许可持有人
Gedeon Ricther Plc. Gyömrõy út 19-21 H-1103 Budapest Ungarn
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Portugal (PT)
Estinette
Italy (IT)
许可日期
2005/09/28
最近更新日期
2023/01/03
药物ATC编码
G03AA10 gestodene and ethinylestradiol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
0799_037 common_spc_clean
Date of last change:2023/03/16
Final PL
|
0799_037 common_pil_clean
Date of last change:2023/03/16
Final Product Information
|
common-spc-clean
Date of last change:2021/12/24
Final Product Information
|
common-pl-clean
Date of last change:2021/12/24
Final Labelling
|
common-other-clean
Date of last change:2011/09/07
Final Labelling
|
common-other-track
Date of last change:2011/09/07
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase