欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1262/002
药品名称
Eplerenona Biofarmoz
活性成分
Eplerenone 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Biofarmoz - Sociedade Técnico Medicinal, Unip. Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2015/06/03
最近更新日期
2025/02/13
药物ATC编码
C03DA04 eplerenone
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial 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
PubAR
|
1262_Eplerenona_Biofarmoz_PAR_genericos_Final_02JUL2018
Date of last change:2024/09/06
Final Product Information
|
immediate_packaging
Date of last change:2024/09/06
Final Product Information
|
outer_packaging_clean
Date of last change:2024/09/06
Final Product Information
|
package_leaflet_25mg_clean_version
Date of last change:2024/09/06
Final Product Information
|
package_leaflet_50mg_clean_version
Date of last change:2024/09/06
Final Product Information
|
summary_product_characteristics_25mg_clean_version
Date of last change:2024/09/06
Final Product Information
|
summary_product_characteristics_50mg_clean_version
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase