欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2153/005
药品名称Rivaroxaban STADA
活性成分
    • Rivaroxaban 15.0 mg
    • Rivaroxaban 20.0 mg
剂型Film-coated tablet
上市许可持有人STADA Arzneimittel AG, Germany
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Netherlands (NL)
      Rivaroxaban CF 15 mg + 20 mg, filmomhulde tabletten
    • Lithuania (LT)
      Rivaroxaban STADA 15 mg plėvele dengtos tabletės Rivaroxaban STADA 20 mg plėvele dengtos tabletės
    • Luxembourg (LU)
    • Estonia (EE)
    • Iceland (IS)
    • Hungary (HU)
      Rivaroxaban STADA 15 mg filmtabletta + Rivaroxaban STADA 20 mg filmtabletta
    • Ireland (IE)
    • Romania (RO)
      Rivaroxaban STADA 15mg+20mg comprimate filmate
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Greece (GR)
    • Germany (DE)
      Rivaroxaban AL Starterpackung 15 mg und 20 mg Filmtabletten
    • Norway (NO)
    • Denmark (DK)
    • Finland (FI)
    • Belgium (BE)
      Rivaroxaban EG 15 mg filmomhulde tabletten + 20 mg filmomhulde tabletten
    • Latvia (LV)
许可日期2022/09/14
最近更新日期2025/04/23
药物ATC编码
    • B01AF01 rivaroxaban
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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