欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0892/001
药品名称
Finasterida Biorga
活性成分
Finasteride 1.0 mg
剂型
Film-coated tablet
上市许可持有人
Laboratoires Bailleul - Biorga
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Cyprus (CY)
Italy (IT)
Luxembourg (LU)
Greece (GR)
Malta (MT)
Andropecia Biorga 1 mg film-coated tablet
France (FR)
Spain (ES)
许可日期
2012/10/18
最近更新日期
2025/07/22
药物ATC编码
D11AX10 finasteride
申请类型
TypeLevel1:
Abridged
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
Final Labelling
|
common_labelling_finasteride_clean
Date of last change:2025/07/22
Final SPC
|
common_spc_finasteride_clean
Date of last change:2025/07/22
Final PL
|
common_pl_finasteride_tc_3
Date of last change:2025/07/22
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase