欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号MT/H/0675/001
药品名称Dabigatran Etexilate Zentiva Capsules Hard 75mg
活性成分
    • Dabigatran etexilate mesilate 75.0 mg
剂型Capsule, hard
上市许可持有人Zentiva k.s. U kabelovny 130, Dolní Měcholupy, 102 37 Praha 10 Česká republika
参考成员国 - 产品名称Malta (MT)
Dabigatran Etexilate Zentiva Capsules Hard 75mg
互认成员国 - 产品名称
    • Germany (DE)
      DabigatranetexilatZentiva 75 mg Hartkapseln
    • Denmark (DK)
      Dabigatran etexilate "Zentiva"
    • Spain (ES)
    • Portugal (PT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Croatia (HR)
许可日期2023/12/15
最近更新日期2024/10/31
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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