欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
FR/H/0516/001
药品名称
Seasonique
活性成分
ethinyl estradiol 30.0 µg
ethinyl estradiol 10.0 µg
Levonorgestrel 150.0 µg
剂型
Film-coated tablet
上市许可持有人
THERAMEX IRELAND LIMITED
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Netherlands (NL)
Spain (ES)
Luxembourg (LU)
Germany (DE)
Seasonique 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten
Belgium (BE)
Seasonique, filmomhulde tabletten
Austria (AT)
Seasonique 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten
Hungary (HU)
SEASONIQUE 150 mikrogramm/30 mikrogramm + 10 mikrogramm filmtabletta
Italy (IT)
Poland (PL)
Seasonique
Portugal (PT)
Romania (RO)
SEASONIQUE 150 micrograme/30 micrograme + 10 micrograme comprimate filmate
Slovakia (SK)
Seasonique
Czechia (CZ)
Seasonique
Slovenia (SI)
许可日期
2015/01/13
最近更新日期
2025/01/11
药物ATC编码
G03AA07 levonorgestrel and ethinylestradiol
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
common_pl_clean_FR_H_0516_001
Date of last change:2025/01/11
Final SPC
|
common_spc_clean_FR_H_0516_001
Date of last change:2025/01/11
Final Labelling
|
common_impack_daylabel_clean_0085
Date of last change:2024/09/06
Final Product Information
|
common_pl_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_clean
Date of last change:2024/09/06
PubAR
|
Public AR _ SeasoniqueFRH0516001DC Scientific discussion _22062015
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase