欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SI/H/0254/002
药品名称Dabigatran Etexilate Krka 110 mg capsules, hard
活性成分
    • Dabigatran etexilate mesilate 110.0 mg
剂型Capsule, hard
上市许可持有人KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia
参考成员国 - 产品名称Slovenia (SI)
Dabigatraneteksilat Krka 110 mg, trde kapsule
互认成员国 - 产品名称
    • Iceland (IS)
    • Ireland (IE)
    • Portugal (PT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
      Dabigatranetexilat Krka
    • United Kingdom (Northern Ireland) (XI)
    • Denmark (DK)
      Dabigatran etexilate Krka
许可日期2023/10/20
最近更新日期2024/11/20
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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    市场状态Positive
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