欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/6866/002
药品名称Clobazam 10 mg/ 5 ml Oral Suspension
活性成分
    • clobazam 10.0 mg
    • clobazam 5.0 ml
剂型Oral suspension
上市许可持有人Teva Pharmaceuticals Europe B.V. [C/O Teva UK Ltd,] Field House Station Approach Harlow Essex CM20 2FB United Kingdom
参考成员国 - 产品名称United Kingdom (GB)
互认成员国 - 产品名称
    • Bulgaria (BG)
      Clobazam Teva
    • Romania (RO)
      Clobazam Teva 10 mg/5 ml suspensie orala
许可日期2018/12/17
最近更新日期2019/08/28
药物ATC编码
    • N05BA09 clobazam
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:2.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided could allow to conclude on a positive benefit-risk balance if the points for clarification identified were solved.
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