欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1326/001
药品名称
Leticia
活性成分
desogestrel 150.0 µg
ethinylestradiol 30.0 µg
剂型
Film-coated tablet
上市许可持有人
Gedeon Richter Plc H-1103 Budapest Gyömröi ùt 19-21 Hungary
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Belgium (BE)
Desorelle 30, 150/30 microgrammes, filmcoated tablet
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
许可日期
2008/09/05
最近更新日期
2023/06/19
药物ATC编码
G03AA09 desogestrel and ethinylestradiol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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_lab_clean
Date of last change:2024/09/06
Final PL
|
DK_H_1326_001_IB_024 Leticia _ Common PIL clean
Date of last change:2024/09/06
Final SPC
|
DK_H_1326_001_IB_024 Leticia _ Common SPC clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase