欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SI/H/0253/003
药品名称Daxanlo 150 mg capsules, hard
活性成分
    • Dabigatran etexilate mesilate 150.0 mg
剂型Capsule, hard
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)
Dabixom 150 mg trde kapsule
互认成员国 - 产品名称
    • Greece (GR)
    • Poland (PL)
      Dabixom
    • Latvia (LV)
    • Lithuania (LT)
      Daxanlo150 mg kietosios kapsulės
    • Estonia (EE)
    • Hungary (HU)
      Daxanlo 150 mg kemény kapszula
    • Bulgaria (BG)
      Dabixom
    • Cyprus (CY)
      Dabixom 150 mg capsules, hard
    • Czechia (CZ)
      Dabixom
    • Romania (RO)
      Dabixom 150 mg capsule
    • Slovakia (SK)
    • Croatia (HR)
许可日期2023/10/20
最近更新日期2024/11/20
药物ATC编码
    • B01AE07 dabigatran etexilate
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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