欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3250/001
药品名称Busalair 120/20 mcg
活性成分
    • budesonide 120.0 µg
    • salmeterol xinafoat 20.0 µg
剂型Inhalation powder, hard capsule
上市许可持有人Laboratoires SMB S.A. rue de la Pastorale 26-28 1080 Brussels Belgium
参考成员国 - 产品名称Netherlands (NL)
Busalair 120 mcg/20 mcg, inhalatiepoeder in harde capsules
互认成员国 - 产品名称
    • Denmark (DK)
    • Portugal (PT)
    • Greece (GR)
      BUSALAIR
    • Sweden (SE)
    • Poland (PL)
    • Hungary (HU)
      REVIX AXAHALER 120 mikrogramm/20 mikrogramm inhalációs por kemény kapszulában
    • Bulgaria (BG)
      Busalair
    • Romania (RO)
      BUSALAIR 120/20 µg Capsule cu pulbere de inhalat
许可日期2015/07/23
最近更新日期2020/08/04
药物ATC编码
    • R03AK06 salmeterol and fluticasone
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Multiple (Copy) 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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