欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/2475/002
药品名称Edoxaban Sandoz
活性成分
    • edoxaban tosylate hydrate 30.0 mg
剂型Film-coated tablet
上市许可持有人Sandoz A/S
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Finland (FI)
    • Hungary (HU)
      Edoxaban Sandoz
    • Germany (DE)
      Edoxaban HEXAL 30 mg Filmtabletten
    • Czechia (CZ)
      Edoxaban Sandoz 30 mg potahované tablety
    • Denmark (DK)
      Edoxaban ”Sandoz”
    • Slovakia (SK)
    • Belgium (BE)
      Edoxaban Sandoz 30 mg filmomhulde tabletten
    • Netherlands (NL)
      Edoxaban Sandoz 30 mg, filmomhulde tabletten
    • Iceland (IS)
    • Ireland (IE)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
许可日期2024/11/27
最近更新日期2024/12/20
药物ATC编码
    • B01AF03 edoxaban
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Additional Strength/Form
  • 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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