欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号MT/H/0583/001
药品名称Dabigatran Etexilate Diagonalis 75 mg hard capsules
活性成分
    • Dabigatran etexilate mesilate 75.0 mg
剂型Capsule, hard
上市许可持有人Galenicum Health S.L. Av. Diagonal 123 Planta 11 08005 – Barcelona Spain
参考成员国 - 产品名称Malta (MT)
Dabigatran Etexilate Diagonalis 75 mg hard capsules
互认成员国 - 产品名称
    • Slovenia (SI)
    • Czechia (CZ)
      DABIGATRAN ETEXILATE DIAGONALIS
    • Slovakia (SK)
    • Austria (AT)
    • Bulgaria (BG)
    • Estonia (EE)
    • Croatia (HR)
    • Lithuania (LT)
      -
    • Latvia (LV)
    • Poland (PL)
      Dafrixab
    • Romania (RO)
      Dabigatran Eteksylan Diagonalis 75 mg capsule
许可日期2022/09/15
最近更新日期2024/02/26
药物ATC编码
    • B01AE07 dabigatran etexilate
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Multiple (Copy) Application
  • TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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