欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2630/005
药品名称Sitagliptin/Dapagliflozin Rontis
活性成分
    • Dapagliflozin 5.0 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
    • Latvia (LV)
    • Hungary (HU)
    • Poland (PL)
      DALZIOR Plus
    • Lithuania (LT)
      Sitagliptin/Dapagliflozin Teva 100 mg/5 mg plėvele dengtos tabletės
    • Austria (AT)
    • Romania (RO)
      Sitagliptin/Dapagliflozin Rontis 100mg/5 mg film-coated tablets
    • Croatia (HR)
    • Germany (DE)
      Sitagliptin/Dapagliflozin Rontis 100 mg/5 mg Filmtabletten
    • Bulgaria (BG)
      Sitagliptin/Dapagliflozin Rontis 100mg/5mg film-coated tablets
    • Italy (IT)
    • Estonia (EE)
许可日期2025/11/06
最近更新日期2025/12/09
药物ATC编码
    • A10BD Combinations of oral blood glucose lowering drugs
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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