欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0105/002
药品名称
Ercostrol
活性成分
Estradiol 1.0 mg/dose
剂型
Gel
上市许可持有人
Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Italy (IT)
Sweden (SE)
许可日期
1996/10/31
最近更新日期
2025/02/03
药物ATC编码
G03CA03 estradiol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
DK_H_0105 Common PIL cl
Date of last change:2024/09/06
Final Labelling
|
EU Ercostrol LABEL 120521
Date of last change:2024/09/06
Final PL
|
EU Ercostrol PIL 140723 clean
Date of last change:2024/09/06
Final SPC
|
EU Ercostrol SPC 140723 clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase