欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/6446/001
药品名称Doxepin Hydrochloride 25mg Capsules
活性成分
    • Doxepin hydrochloride 25.0 mg
剂型Capsule, hard
上市许可持有人RPH Pharmaceuticals AB c/o Recipharm Limited Vale of Bardsley Ashton-Under-Lyne OL7 9RR United Kingdom
参考成员国 - 产品名称United Kingdom (UK)
互认成员国 - 产品名称
    • Luxembourg (LU)
许可日期2019/06/21
最近更新日期2019/06/21
药物ATC编码
    • N06AA12 doxepin
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic
  • 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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