欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2315/001
药品名称Dabigatran Etexilate Viatris
活性成分
    • Dabigatran etexilate mesilate 75.0 mg
剂型Capsule, hard
上市许可持有人Viatris Limited, Ireland
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Greece (GR)
    • Slovakia (SK)
    • Germany (DE)
      Dabigatranetexilat Vale 75 mg Hartkapseln
    • Norway (NO)
    • Slovenia (SI)
    • Denmark (DK)
      Dabigatran Etexilate Viatris
    • Finland (FI)
    • Malta (MT)
      Dabigatran Etexilate Vale 75mg hard capsules
    • Belgium (BE)
    • Poland (PL)
      Dabigatran Etexilate Vale
    • Croatia (HR)
    • Netherlands (NL)
    • Latvia (LV)
    • Luxembourg (LU)
    • Lithuania (LT)
      Dabigatran etexilate Vale 75 mg kietosios kapsulės
    • Iceland (IS)
    • Estonia (EE)
    • Austria (AT)
    • Hungary (HU)
    • France (FR)
    • Bulgaria (BG)
      Dabigatran etexilate Vale
    • Spain (ES)
    • Cyprus (CY)
      Dabigatran Etexilate Vale 75 mg Kαψάκιο, σκληρό
    • Portugal (PT)
    • Czechia (CZ)
      Dabigatran Etexilate Vale
    • Italy (IT)
    • Romania (RO)
      Dabigatran Etexilat Vale 75 mg capsule
许可日期2023/12/21
最近更新日期2025/09/04
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Positive
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