欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/6359/001
药品名称Lifsar 50 microgram/250 microgram per metered dose inhalation powder
活性成分
    • fluticasone propionate 50.0 µg
    • salmeterol xinafoate propionate 250.0 µg
剂型-
上市许可持有人Zentiva k.s.
参考成员国 - 产品名称United Kingdom (GB)
互认成员国 - 产品名称
    • Germany (DE)
      Lifsar Pulmojet 50 µg/250 µg
    • Malta (MT)
    • Norway (NO)
    • Latvia (LV)
    • Lithuania (LT)
    • Liechtenstein (LI)
    • Italy (IT)
    • Ireland (IE)
    • Estonia (EE)
    • Denmark (DK)
    • Czechia (CZ)
      Lifsar Pulmojet 50 mikrogramů/250 mikrogramů
    • Bulgaria (BG)
    • Austria (AT)
    • Slovakia (SK)
    • Portugal (PT)
    • Poland (PL)
    • Romania (RO)
许可日期2017/06/13
最近更新日期2017/07/28
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:3.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided was sufficient to conclude on a positive benefit-risk balance.
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