欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1076/001
药品名称
Sinvastatina Aurovitas
活性成分
simvastatin 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
许可日期
2013/11/12
最近更新日期
2024/01/19
药物ATC编码
C10AA01 simvastatin
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
|
056966_056967_056968_20160219_PAR_IRS
Date of last change:2024/09/06
Final Product Information
|
common_labelling_clean
Date of last change:2024/09/06
Final Product Information
|
common_pi_version_clean
Date of last change:2024/09/06
Final PL
|
common_pl_proposedclean
Date of last change:2024/09/06
Final SPC
|
common_spc_proposedclean
Date of last change:2024/09/06
Final Product Information
|
common_spc_version_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase