欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2218/003
药品名称Dabigatran etexilate Medical Valley
活性成分
    • Dabigatranetexilatmesilat mesilate 150.0 mg
剂型Capsule, hard
上市许可持有人Medical Valley Invest AB Sweden
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Denmark (DK)
      Dabigatran etexilate ”Medical Valley”
    • Netherlands (NL)
    • Iceland (IS)
    • Ireland (IE)
    • Spain (ES)
    • Norway (NO)
    • Poland (PL)
      Dabigatran Medical Valley
    • Romania (RO)
      Dabigatran etexilate Liconsa 150 mg capsule
    • Croatia (HR)
    • Germany (DE)
      Dabigatran AXiromed 150 mg Hartkapseln
许可日期2024/06/26
最近更新日期2025/08/13
药物ATC编码
    • B01AE07 dabigatran etexilate
申请类型
  • TypeLevel1：Abridged
  • 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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市场状态Positive
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