欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号UK/H/5976/001
药品名称Ibuprofen 400 mg film-coated tablets
活性成分
    • ibuprofen 400.0 mg
剂型Film-coated tablet
上市许可持有人Alkem Pharma GmbH
参考成员国 - 产品名称United Kingdom (GB)
互认成员国 - 产品名称
    • Germany (DE)
      Ibuprofen 400 mg Filmtabletten
    • Spain (ES)
    • Poland (PL)
      Ibuprofen Alkem
许可日期2016/04/04
最近更新日期2017/08/29
药物ATC编码
    • M01AE01 ibuprofen
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Generic Art 10.1 and 10.2 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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