欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1342/004
药品名称Hidrasec
活性成分
    • racecadotril 4.0 mg/ml
剂型Oral suspension
上市许可持有人Bioprojet Europe Limited, Ireland
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Italy (IT)
许可日期2024/05/10
最近更新日期2024/05/13
药物ATC编码
    • A07XA04 racecadotril
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) 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.
    ©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase