欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/2598/001
药品名称Ezetimib/Simvastatin "Krka"
活性成分
    • ezetimibe 10.0 mg
    • simvastatin 10.0 mg
剂型Tablet
上市许可持有人Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
参考成员国 - 产品名称Denmark (DK)
Ezetimib/Simvastatin Krka
互认成员国 - 产品名称
    • Iceland (IS)
    • Germany (DE)
    • Belgium (BE)
      Ezetimibe/Simvastatine Krka 10 mg/10 mg tabletten
    • Netherlands (NL)
      Ezetimibe/Simvastatine Krka 10mg/10mg tabletten
    • Ireland (IE)
    • Austria (AT)
      Ezetimib/Simvastatin Krka 10 mg/10 mg Tabletten
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
      VASITIMB
    • Sweden (SE)
    • Norway (NO)
      Ezetimib/Simvastatin Krka
    • Slovenia (SI)
      Vasitimb 10 mg/10 mg tablete
    • Croatia (HR)
      Vasitimb 10 mg/10 mg tablete
许可日期2016/12/21
最近更新日期2023/11/30
药物ATC编码
    • C10BA02 simvastatin and ezetimibe
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
市场状态Positive
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