欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0547/001
药品名称
Apleek
活性成分
ethinyl estradiol 0.55 mg
gestodene 2.1 mg
剂型
Transdermal patch
上市许可持有人
Bayer Pharma AG
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Luxembourg (LU)
apleek 60mcg / 24H + 13mcg /24H Dispositif transdermique
Iceland (IS)
apleek 60 míkróg/24 klst. + 13 míkróg/24 klst. Forðaplástur
United Kingdom (Northern Ireland) (XI)
Spain (ES)
Italy (IT)
Poland (PL)
apleek
Estonia (EE)
APLEEK
Cyprus (CY)
APLEEK TRANSDERMAL PATCH
Malta (MT)
apleek 60 micrograms/24 hours + 13 micrograms/24 hours transdermal patch
Belgium (BE)
Slovakia (SK)
许可日期
2014/02/11
最近更新日期
2024/08/19
药物ATC编码
G03AA10 gestodene and ethinylestradiol
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
Public AR _ Scientific discussion _ Apleek
Date of last change:2024/09/06
PubAR
|
Summary Public AR_Apleek
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase