欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SI/H/0252/002
药品名称Dapagliflozin Krka 10 mg film-coated tablets
活性成分
    • Dapagliflozin 10.0 mg
    • dapagliflozin--(2R)-propane-1,2-diol (1:1) 1 H2O 12.3 mg
剂型Film-coated tablet
上市许可持有人KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称Slovenia (SI)
Dapagliflozin Krka 10 mg filmsko obložene tablete
互认成员国 - 产品名称
    • Norway (NO)
    • Finland (FI)
      Dapagliflozin Krka
    • Denmark (DK)
      Dapagliflozin "Krka"
    • Iceland (IS)
    • Ireland (IE)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Sweden (SE)
许可日期2023/09/15
最近更新日期2025/01/10
药物ATC编码
    • A10BK01 dapagliflozin
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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市场状态Positive
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