欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/1322/003
药品名称Salmeterol/Fluticasone Hexal
活性成分
    • fluticasone propionate 250.0 µg/dose
    • salmeterol xinafoate 50.0 µg/dose
剂型Inhalation powder, pre-dispensed
上市许可持有人Hexal A/S Edvard Thomsens Vej 14 DK-2300 Kobenhavn S Denmark
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    许可日期2015/04/15
    最近更新日期2015/09/02
    药物ATC编码
      • R03AK06 salmeterol and fluticasone
    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Withdrawn（注：已撤市）
      撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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