欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0642/006
药品名称
Atorvastatin Krka
活性成分
Atorvastatin calcium 60.0 mg
剂型
Film-coated tablet
上市许可持有人
KRKA Sverige AB Sweden
参考成员国 - 产品名称
Sweden (SE)
Atorvastatin Krka
互认成员国 - 产品名称
Belgium (BE)
Atorvastatin HCS 60 mg filmomhulde tabletten
Austria (AT)
Atorvastatin Krka 60 mg Filmtabletten
Italy (IT)
Greece (GR)
Cyprus (CY)
ATORVASTATIN KRKA 60mg FC TABS
Romania (RO)
Atoris 60 mg, comprimate filmate
许可日期
2011/03/10
最近更新日期
2025/01/15
药物ATC编码
C10AA05 atorvastatin
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_0642_006_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0642_006_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0642_006_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase