欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1473/002
药品名称
Estelle
活性成分
Ethinylestradiol 20.0 µg
Levonorgestrel 100.0 µg
剂型
Film-coated tablet
上市许可持有人
Mylan Germany GmbH Lütticher Straße 5 53842 Troisdorf Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Netherlands (NL)
Elevin
France (FR)
Italy (IT)
许可日期
2009/12/15
最近更新日期
2025/01/22
药物ATC编码
G03AA07 levonorgestrel and ethinylestradiol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 SPC
|
common_spc_20_100
Date of last change:2025/01/23
Final PL
|
common_pl_20_100
Date of last change:2025/01/23
PubAR
|
04_DE_1473_1582_1_2_DC Elevin_final PAR
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_1473_V043
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_1473_V043
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase