欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号CZ/H/1060/001
药品名称RoxaBana 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Swyssi AG, Lyoner Strasse 14, Franfurt am Main 60528, Germany
参考成员国 - 产品名称Czechia (CZ)
Roxabana
互认成员国 - 产品名称
    • Portugal (PT)
    • Romania (RO)
      RoxaBana 10 mg comprimate filmate
    • Slovakia (SK)
许可日期2022/07/06
最近更新日期2024/06/20
药物ATC编码
    • B01AF01 rivaroxaban
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
附件文件下载
市场状态Positive
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