欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/2214/001
药品名称Salmeterol Orifarm
活性成分
    • salmeterol xinafoat 50.0 µg/dose
剂型Inhalation powder, pre-dispensed
上市许可持有人Orifarm Healthcare A/S Denmark
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Denmark (DK)
    • Norway (NO)
    • Finland (FI)
许可日期2022/09/27
最近更新日期2022/10/07
药物ATC编码
    • R03AC12 salmeterol
申请类型
  • TypeLevel1:Abridged
  • 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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