欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1213/004
药品名称Bufomix Easyhaler
活性成分
    • budesonide 80.0 µg/inhalation
    • formoterol fumarate 4.5 µg/inhalation
剂型Inhalation powder
上市许可持有人Orion Corporation Finland
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
      Bufomix Easyhaler 80 microgram/4,5 microgram/inhalatie, Inhalatiepoeder/ Poudre pour inhalation/ Pul
    • Luxembourg (LU)
      Bufomix Easyhaler 80 mcg / 4,5 mcg Poudre pour inhalation
    • Iceland (IS)
      Bufomix Easyhaler 80/4,5 míkróg/skammt Innöndunarduft
    • Ireland (IE)
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
      Bufomix Easyhaler
    • Finland (FI)
    • Poland (PL)
      Bufomix Easyhaler
    • Latvia (LV)
      Bufomix Easyhaler 80 mikrogrami/4,5 mikrogrami/inhalācijā, inhalācijas pulveris
    • Lithuania (LT)
      Bufomix Easyhaler 80 mikrogramų/4,5 mikrogramo/dozėje įkvepiamieji milteliai
    • Estonia (EE)
      BUFOMIX EASYHALER
    • Hungary (HU)
      BUFOMIX EASYHALER 4,5 mikrogramm/80 mikrogramm/belégzés inhalációs por
    • Bulgaria (BG)
      Bufomyx Easyhaler
    • Czechia (CZ)
      Bufomix Easyhaler 80 mikrogramů/4,5 mikrogramů
    • Slovakia (SK)
      Bufomix Easyhaler 80 mikrogramov/4,5 mikrogramov
    • Slovenia (SI)
许可日期2016/02/11
最近更新日期2023/05/26
药物ATC编码
    • R03AK07 formoterol and budesonide
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Initial Application
  • TypeLevel3:Other Generic application Art 10.3 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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