欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号HU/H/0388/003
药品名称ROSUDAPIN 20 mg/5 mg film-coated tablet
活性成分
    • amlodipine besilate 5.0 mg
    • rosuvastatin calcium 20.0 mg
剂型Film-coated tablet
上市许可持有人Krka, d.d., Novo mesto (SI)
参考成员国 - 产品名称Hungary (HU)
Rosudapin 20 mg/5 mg filmtabletta
互认成员国 - 产品名称
    • Poland (PL)
    • Lithuania (LT)
      Rosvaden 20 mg/5 mg plėvele dengtos tabletės
    • Bulgaria (BG)
      Rosudapin
    • Romania (RO)
      ROSUDAPIN
    • Slovenia (SI)
许可日期2015/07/29
最近更新日期2020/03/03
药物ATC编码
    • C10BX Lipid modifying agents in combination with other drugs
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • 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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