欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/2961/002
药品名称Atorvastatin Genericon Pharma
活性成分
    • atorvastatin 20.0 mg
剂型Film-coated tablet
上市许可持有人Genericon Pharma Gesellschaft m.b.H. Hafnerstraße 211 8045 Graz Austria
参考成员国 - 产品名称Denmark (DK)
互认成员国 - 产品名称
    • Austria (AT)
    • Czechia (CZ)
      Atorvan
许可日期2020/01/22
最近更新日期2020/01/28
药物ATC编码
    • C10AA05 atorvastatin
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Additional Strength/Form
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Withdrawn(注:已撤市)
    撤市原因:1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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