欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/0381/002
药品名称Dotarem 0.5 mmol/ml (for multiple use), solution for injection
活性成分
    • gadoteric acid 0.5 mmol/ml
剂型Solution for injection
上市许可持有人Guerbet 15 rue des Vanesses 93420, Villepinte France
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Germany (DE)
    • Poland (PL)
    • Latvia (LV)
    • Lithuania (LT)
      DOTAREM (daugiadozis) 0,5mmol/ml injekcinis tirpalas
    • Estonia (EE)
    • Cyprus (CY)
      DOTAREM SOL FOR INJECTION
    • Slovakia (SK)
许可日期2003/05/28
最近更新日期2024/07/15
药物ATC编码
    • V08CA02 gadoteric acid
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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