欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号PT/H/0702/001
药品名称Amoxicilina + Ácido Clavulânico Aurobindo
活性成分
    • amoxicillin trihydrate 400.0 mg/5ml
    • clavulanic acid 57.0 mg/5ml
剂型Powder for oral solution
上市许可持有人Aurobindo Pharma (Portugal), Unip. Lda.
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Italy (IT)
    • Romania (RO)
      Amoxicilină/Acid clavulanic Aurobindo 400 mg/57 mg/5 ml pulbere pentru suspensie orala
    • Malta (MT)
      Co-amoxiclav 400mg/57mg/5ml Powder for Oral suspension
许可日期2012/08/02
最近更新日期2023/10/06
药物ATC编码
    • J01CR02 amoxicillin and beta-lactamase inhibitor
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
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