欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号PT/H/1280/001
药品名称DRILLfen
活性成分
    • ibuprofen 25.0 mg
剂型Lozenge
上市许可持有人Pierre Fabre Dermo-Cosmétique Portugal, Lda.
参考成员国 - 产品名称Portugal (PT)
DRILLfen
互认成员国 - 产品名称
    • Belgium (BE)
    • Bulgaria (BG)
      DRILLfen
    • Cyprus (CY)
    • Czechia (CZ)
      DRILLfen
    • Greece (GR)
      DRILLFEN
    • France (FR)
    • Italy (IT)
    • Luxembourg (LU)
    • Poland (PL)
    • Romania (RO)
      DRILLfen 25 mg pastile
    • Slovakia (SK)
许可日期2015/12/01
最近更新日期2016/02/04
药物ATC编码
    • R02AX Other throat preparations
申请类型
  • TypeLevel1：Known Active Substance
  • 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.
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