欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2456/001
药品名称Edoxaban Teva
活性成分
    • edoxaban tosilate monohydrate 15.0 mg
剂型Film-coated tablet
上市许可持有人Teva GmbH, Germany
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Belgium (BE)
      Edoxaban Teva 15 mg filmomhulde tabletten
    • Czechia (CZ)
      Edoxaban Teva
    • Netherlands (NL)
      Edoxaban Teva 15 mg, filmomhulde tabletten
    • Romania (RO)
      Edoxaban Teva 15 mg comprimate filmate
    • Luxembourg (LU)
    • Slovakia (SK)
    • Iceland (IS)
    • Ireland (IE)
    • Austria (AT)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
    • Germany (DE)
      Edoxaban-ratiopharm 15 mg Filmtabletten
    • Finland (FI)
    • Denmark (DK)
      Edoxaban Teva
    • Hungary (HU)
许可日期2025/01/22
最近更新日期2025/09/10
药物ATC编码
    • B01AF03 edoxaban
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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