欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号FI/H/0146/005
药品名称Simvastatin Hexal 40 mg
活性成分
    • simvastatin 40.0 mg
剂型Film-coated tablet
上市许可持有人Hexal A/S Kanalholmen 8-12 2650 HVIDOVRE Denmark
参考成员国 - 产品名称Finland (FI)
互认成员国 - 产品名称
    • Germany (DE)
    • Denmark (DK)
    • Spain (ES)
      SIMVASTATINA LABIBEX 40 mg comprimidos recubiertos con película
    • Italy (IT)
    • Sweden (SE)
    • Poland (PL)
许可日期2001/10/03
最近更新日期2008/09/23
药物ATC编码
    • C CARDIOVASCULAR SYSTEM
    • C10 LIPID MODIFYING AGENTS
    • C10A LIPID MODIFYING AGENTS, PLAIN
    • C10AA HMG CoA reductase inhibitors
    • C10AA01 simvastatin
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Article 4.8(a)(iii), first paragraph
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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    市场状态Positive
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