欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4377/002
药品名称Ibuprofen Strides 600 mg prolonged release tablets
活性成分
    • ibuprofen 600.0 mg
剂型Prolonged-release tablet
上市许可持有人Strides Arcolab International Limited
参考成员国 - 产品名称Netherlands (NL)
Ibuprofen Strides 600 mg tabletten met verlengde afgifte
互认成员国 - 产品名称
    • Belgium (BE)
    • France (FR)
    • Germany (DE)
      2202417
    • Spain (ES)
    • United Kingdom (GB)
许可日期2019/10/31
最近更新日期2019/11/07
药物ATC编码
    • M01AE01 ibuprofen
申请类型
  • TypeLevel1:Abridged
  • 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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