欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/5688/002
药品名称Adrenaline 5mg/5ml (1:1,000), solution for injection in pre-filled syringe
活性成分
    • epinephrine 5.0 mg/5ml
剂型SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE
上市许可持有人LABORATOIRE AGUETTANT
参考成员国 - 产品名称United Kingdom (GB)
Adrenaline 5mg/5ml (1:1,000), solution for injection in pre-filled syringe
互认成员国 - 产品名称
    • Germany (DE)
      Adrenaline 5 mg/5 ml (1:1,000) Aguettant Injektionslösung in Fertigspritze
    • Belgium (BE)
    • Luxembourg (LU)
    • Netherlands (NL)
    • Austria (AT)
    • Spain (ES)
    • France (FR)
    • Ireland (IE)
    • Italy (IT)
许可日期2015/11/13
最近更新日期2015/11/25
药物ATC编码
    • C01CA24 epinephrine
申请类型
  • TypeLevel1:Abridged
  • 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.
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