欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2630/006
药品名称Sitagliptin/Dapagliflozin Teva
活性成分
    • Dapagliflozin 10.0 mg
    • Sitagliptin 100.0 mg
剂型Film-coated tablet
上市许可持有人Teva B.V. Netherlands
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Bulgaria (BG)
      Sitagliptin/Dapagliflozin Rontis 100mg/10mg film-coated tablets
    • Romania (RO)
      Sitagliptin/Dapagliflozin Rontis 100mg/10 mg film-coated tablets
    • Croatia (HR)
    • Germany (DE)
      Sitagliptin/Dapagliflozin Rontis 100 mg/10 mg Filmtabletten
    • Austria (AT)
    • Italy (IT)
    • Poland (PL)
      Sitagliptin/Dapagliflozin Rontis
    • Latvia (LV)
    • Lithuania (LT)
      Sitagliptin/Dapagliflozin Teva 100 mg/10 mg plėvele dengtos tabletės
    • Estonia (EE)
    • Hungary (HU)
许可日期2025/11/19
最近更新日期2025/12/19
药物ATC编码
    • A10BD29 sitagliptin and dapagliflozin
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Fixed Combination
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
附件文件下载
    市场状态Positive
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