欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号FI/H/0827/001
药品名称Betaserc
活性成分
    • betahistine dihydrochloride 24.0 mg
剂型Orodispersible tablet
上市许可持有人Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate DUBLIN 13 Ireland
参考成员国 - 产品名称Finland (FI)
Betaserc
互认成员国 - 产品名称
    • Portugal (PT)
    • Greece (GR)
      BETASERC
    • Poland (PL)
      Betaserc ODT
    • Latvia (LV)
      Betaserc 24 mg mutē disperģējamās tabletes
    • Lithuania (LT)
      Betaserc 24 mg burnoje disperguojamosios tabletės
    • Estonia (EE)
      BETASERC
    • Bulgaria (BG)
      Betaserc
    • Cyprus (CY)
      BETASERC ORODISPERSIBLE TABS
    • Romania (RO)
      Betaserc 24 mg Comprimate orodispersabile
    • Slovenia (SI)
      Betaserc 24 mg orodisperzibilne tablete
许可日期2014/11/19
最近更新日期2022/11/04
药物ATC编码
    • N07CA01 betahistine
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) 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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