欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/2544/001
药品名称Rivaroxaban/Acetylsalicylic acid PharOS 2.5 mg/50 mg hard capsules
活性成分
    • ACETYL SALICYLIC ACID 50.0 mg
    • Rivaroxaban 2.5 mg
剂型Capsule, hard
上市许可持有人Pharos Pharmaceutical Oriented Services Ltd.
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
      Rivaroxaban/Acetylsalicylic acid PharOS 2,5 mg/50 mg Hartkapseln
    • Malta (MT)
许可日期2025/01/15
最近更新日期2025/07/01
药物ATC编码
    • N02BA01 acetylsalicylic acid
    • B01AF01 rivaroxaban
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Fixed combination Art 10b Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Withdrawn(注:已撤市)
    撤市原因:1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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