欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5431/002
药品名称Xiltess 10 mg film-coated tablets
活性成分
    • RIVAROXABAN 10.0 mg
剂型Film-coated tablet
上市许可持有人Egis Pharmaceuticals Plc. Keresztúri út 30-38 Budapest, 1106 Hungary
参考成员国 - 产品名称Netherlands (NL)
Xiltess 10 mg filmomhulde tabletten
互认成员国 - 产品名称
    • Hungary (HU)
      Renex 10 mg filmtabletta
    • Bulgaria (BG)
      Renex
    • Czechia (CZ)
      Renex
    • Romania (RO)
      Renex 10 mg comprimate filmate
    • Slovakia (SK)
    • Poland (PL)
      Xiltess
    • Latvia (LV)
    • Lithuania (LT)
      -
许可日期2022/11/21
最近更新日期2024/05/30
药物ATC编码
    • B01AF01 rivaroxaban
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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