欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1938/001
药品名称Paracetamol/Ibuprofen Suspension Vale
活性成分
    • ibuprofen 9.6 mg/ml
    • paracetamol 32.0 mg/ml
剂型Oral suspension
上市许可持有人Vale Pharmaceuticals Limited, Ireland
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Bulgaria (BG)
    • Romania (RO)
    • Croatia (HR)
    • Hungary (HU)
    • Lithuania (LT)
      -
    • Estonia (EE)
    • Slovakia (SK)
    • Slovenia (SI)
    • Czechia (CZ)
      Combogesic 160 mg/ 48 mg/ 5 ml oral suspension
    • Latvia (LV)
许可日期2020/04/21
最近更新日期2020/07/07
药物ATC编码
    • N02BE51 paracetamol, combinations excl. psycholeptics
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: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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