欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号UK/H/6162/001
药品名称Ibuprofen & Codeine Phosphate Hemihydrate 200mg/12.8mg Tablets
活性成分
    • Codeine phosphate hemihydrate 12.8 mg
    • Ibuprofen 200.0 mg
剂型Film-coated tablet
上市许可持有人Omega Pharma Limited, 1st floor, 32 Vauxhall Bridge Road, London SW1V 2SA
参考成员国 - 产品名称United Kingdom (UK)
Ibuprofen & Codeine Phosphate Hemihydrate 200mg/12.8mg Tablets
互认成员国 - 产品名称
    • Cyprus (CY)
    • Poland (PL)
      Solpadeine Menstrual
    • Romania (RO)
许可日期2019/05/14
最近更新日期2019/06/18
药物ATC编码
    • M01AE51 ibuprofen, combinations
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • TypeLevel3：Bibliographic
  • 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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