欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/4376/001
药品名称Nurofen Long Lasting 300 mg prolonged release tablets
活性成分
    • ibuprofen 300.0 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)
Nurofen Long Lasting
互认成员国 - 产品名称
    • Austria (AT)
    • Bulgaria (BG)
    • Czechia (CZ)
      Nurofen Long Lasting 300 mg tablety s prodlouženým uvolňováním
    • Croatia (HR)
    • Greece (GR)
    • Hungary (HU)
    • Ireland (IE)
    • Italy (IT)
    • Luxembourg (LU)
    • Poland (PL)
      Nurofen Long Lasting
    • Romania (RO)
    • Slovenia (SI)
    • Slovakia (SK)
许可日期2019/10/31
最近更新日期2020/06/17
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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