欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1815/001
药品名称
Ezetimiba Aurobindo
活性成分
Ezetimibe 10.0 mg
剂型
Tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Ezetimib PUREN 10 mg Tabletten
Belgium (BE)
Ezetimib AB 10 mg tabletten
Netherlands (NL)
Ezetimibe Aurobindo 10 mg, tabletten
France (FR)
Spain (ES)
Poland (PL)
Ezetimibe Aurovitas
许可日期
2018/01/11
最近更新日期
2024/09/19
药物ATC编码
C10AX09 ezetimibe
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
PubAR
|
616182_20180208_PAR_ACM
Date of last change:2024/09/06
Final Product Information
|
Labelling_1815
Date of last change:2024/09/06
Final Product Information
|
PIL_1815
Date of last change:2024/09/06
Final Product Information
|
SPC_1815
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase