欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3679/002
药品名称Rosuvastatin/Ezetimibe Mylan Healthcare 20 mg/10 mg filmcoated tablets
活性成分
    • ezetimibe 10.0 mg
    • rosuvastatin calcium 20.0 mg
剂型Film-coated tablet
上市许可持有人Althera Laboratories Ltd 9 Exchange Place, I.f.s.c. Dublin 1 Ireland
参考成员国 - 产品名称Netherlands (NL)
Rosuvastatine/Ezetimibe Althera 20 mg/10 mg filmomhulde tabletten
互认成员国 - 产品名称
    • Germany (DE)
      Rosuzet 20 mg/10 mg Filmtabletten
许可日期2019/01/09
最近更新日期2023/09/20
药物ATC编码
    • C10BA06 rosuvastatin and ezetimibe
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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