欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SK/H/0247/003
药品名称Dabixom 150 mg capsules hard
活性成分
    • Dabigatranetexilatmesilat 150.0 mg
剂型Capsule, hard
上市许可持有人KRKA, d.d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称Slovakia (SK)
互认成员国 - 产品名称
    • Bulgaria (BG)
      Bigatrin
    • Czechia (CZ)
      Bigatrin
    • Estonia (EE)
    • Croatia (HR)
    • Hungary (HU)
    • Latvia (LV)
    • Lithuania (LT)
      Dabixom 150 mg kietosios kapsulės
    • Poland (PL)
    • Romania (RO)
      Bigatrin 150 mg capsule
    • Slovenia (SI)
    • Spain (ES)
    • Greece (GR)
    • Cyprus (CY)
      Bigatrin 150 mg capsules hard
许可日期2021/04/14
最近更新日期2024/02/06
药物ATC编码
    • B01AE07 dabigatran etexilate
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Withdrawn(注:已撤市)
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