欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号RO/H/0118/001
药品名称Xivulan 1000mg/200mg, powder for solution for injection
活性成分
    • amoxicillin sodium acetate 1000.0 mg
    • clavulanic acid potassium salt 200.0 mg
剂型Powder for solution for injection
上市许可持有人Antibiotice SA, Romania
参考成员国 - 产品名称Romania (RO)
Xivulan 1000mg/200mg, powder for solution for injection
互认成员国 - 产品名称
    • Czechia (CZ)
      Xivulan
    • Estonia (EE)
    • Hungary (HU)
    • Latvia (LV)
    • Poland (PL)
      Xivulan
许可日期2020/10/09
最近更新日期2022/09/29
药物ATC编码
    • J01CR02 amoxicillin and beta-lactamase inhibitor
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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