欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号CZ/H/1263/002
药品名称Rosuvastatin/Ezetimibe Krka d.d.
活性成分
    • ezetimibe 10.0 mg
    • rosuvastatin calcium 10.0 mg
剂型Film-coated tablet
上市许可持有人KRKA d.d., Novo mesto Šmarješka cesta 6 Novo mesto 8501 Slovenia
参考成员国 - 产品名称Czechia (CZ)
Rosuvastatin/Ezetimibe Krka d.d.
互认成员国 - 产品名称
    • Norway (NO)
    • Finland (FI)
    • Belgium (BE)
      Rosuvastatin/Ezetimibe HCS 10 mg/10 mg Filmomhulde tabletten
    • Malta (MT)
    • Portugal (PT)
许可日期2023/10/23
最近更新日期2024/04/16
药物ATC编码
    • C10BA06 rosuvastatin and ezetimibe
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Additional Strength/Form
  • TypeLevel3:Fixed combination Art 10b Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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