欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5138/001
药品名称Monofree Fenil
活性成分
    • phenylephrine hydrochloride 5.0 %
剂型Eye drops, solution in single-dose container
上市许可持有人Laboratoires Thea S.A.S. 12 Rue Louis Bleriot Cs 30454 Clermont Ferrand Cedex 2 63017 France
参考成员国 - 产品名称Netherlands (NL)
Monofree Fenil 5%, oogdruppels, oplossing in verpakking voor éénmalig gebruik
互认成员国 - 产品名称
    • Belgium (BE)
许可日期2021/12/17
最近更新日期2021/12/24
药物ATC编码
    • S01FB01 phenylephrine
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Bibliographic Art 10 a 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.
    ©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase