欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0347/003
药品名称
Atorvastatina Galenicum
活性成分
atorvastatin calcium salt 40.0 mg
剂型
Film-coated tablet
上市许可持有人
Galenicum Health, S.L.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
France (FR)
Germany (DE)
United Kingdom (Northern Ireland) (XI)
许可日期
2011/03/30
最近更新日期
2024/03/08
药物ATC编码
C10AA05 atorvastatin
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 PL
|
pt-spc-trackchanges
Date of last change:2013/04/09
Final PL
|
pt-pl-10mgtrackchanges
Date of last change:2013/04/09
Final PL
|
pt-pl-20mgtrackchanges
Date of last change:2013/04/09
Final PL
|
pt-pl-40mgtrackchanges
Date of last change:2013/04/09
Final Labelling
|
common-outer
Date of last change:2011/03/31
Final Labelling
|
common-outer_2
Date of last change:2011/03/31
Final SPC
|
common-spc
Date of last change:2011/03/31
Final SPC
|
common-spc_2
Date of last change:2011/03/31
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase