欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/3193/002
药品名称Barhemsys
活性成分
    • amisulpride 10.0 mg
剂型Solution for injection
上市许可持有人Acacia Pharma Ireland Limited Vistra Ireland, 32 Merrion Street Upper, Dublin 2, D02KW80 Ireland
参考成员国 - 产品名称Denmark (DK)
Barhemsys
互认成员国 - 产品名称
    • France (FR)
    • Germany (DE)
      Barhemsys 2.5 mg/mL solution for injection
    • Italy (IT)
    • Spain (ES)
许可日期2022/12/06
最近更新日期2022/12/12
药物ATC编码
    • N05AL05 amisulpride
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Additional Strength/Form
  • 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: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