欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/6506/001
药品名称Tantum Verde DOLO 8.75 mg Honey and Lemon lozenges
活性成分
    • flurbiprofen 875.0 mg
剂型Lozenge
上市许可持有人Head Of Regulatory Affairs ACRAF SPA- AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO VIA VECCHIA DEL PINOCCHIO 22 ANCONA AN I-60131 ITALY
参考成员国 - 产品名称United Kingdom (GB)
互认成员国 - 产品名称
    • Portugal (PT)
    • Austria (AT)
    • Bulgaria (BG)
      TANTUM VERDE DOLO
    • Croatia (HR)
    • Czechia (CZ)
      Tantum verde dolo
    • Greece (GR)
      FLURBIPROFEN/ANGELINI PHARMA HELLAS
    • Hungary (HU)
    • Poland (PL)
    • Romania (RO)
    • Slovenia (SI)
    • Slovakia (SK)
    • Spain (ES)
许可日期2019/02/06
最近更新日期2019/08/27
药物ATC编码
    • R02AX01 flurbiprofen
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Other Generic application Art 10.3 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Non Prescription (including OTC)
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.
    ©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase