欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5683/003
药品名称Zetovar 10 mg/40 mg film-coated-tablet
活性成分
    • atorvastatin calcium trihydrate 40.0 mg
    • ezetimibe 10.0 mg
剂型Film-coated tablet
上市许可持有人Zentiva k.s. U Kabelovny 130 Dolní Měcholupy 102 37 Praha-Dolní Měcholupy Czechia
参考成员国 - 产品名称Netherlands (NL)
Zetovar 10mg/40mg filmomhulde tabletten
互认成员国 - 产品名称
    • Germany (DE)
      Ezetimib/Atorvastatin Zentiva 10 mg/ 40 mg Filmtabletten
    • Ireland (IE)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Bulgaria (BG)
许可日期2023/11/29
最近更新日期2024/03/20
药物ATC编码
    • C10BA05 atorvastatin and ezetimibe
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
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市场状态Positive
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