欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/1913/001
药品名称Isaviam
活性成分
    • fluticasone propionate 50.0 µg/dose
    • salmeterol xinafoate 25.0 µg/dose
剂型Inhalation powder, pre-dispensed
上市许可持有人Sun Pharmaceutical Industries Europe B.V. NL
参考成员国 - 产品名称Sweden (SE)
Darespia
互认成员国 - 产品名称
    • Poland (PL)
    • Romania (RO)
许可日期2020/11/06
最近更新日期2021/01/20
药物ATC编码
    • R03AK06 salmeterol and fluticasone
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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