欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/6568/004
药品名称Abstral 400 microgram sublingual tablets
活性成分
    • fentanyl citrate 0.4 mg
剂型Sublingual tablet
上市许可持有人Head Of Regulatory Affairs ACTAVIS UK LIMITED WHIDDON VALLEY BARNSTAPLE EX32 8NS UNITED KINGDOM
参考成员国 - 产品名称United Kingdom (GB)
互认成员国 - 产品名称
    许可日期2019/05/14
    最近更新日期2019/05/29
    药物ATC编码
      • N02AB03 fentanyl
    申请类型
    • TypeLevel1:Abridged
    • TypeLevel2:Initial Application
    • TypeLevel3:Generic Art 10.1 and 10.2 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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