欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4205/001
药品名称Leflunomide Thornton & Ross 10 mg, filmomhulde tabletten
活性成分
    • leflunomide 10.0 mg
剂型Film-coated tablet
上市许可持有人Thornton & Ross Limited Linthwaite, Huddersfield HD7 5QH United Kingdom
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • United Kingdom (GB)
许可日期2018/11/02
最近更新日期2018/11/05
药物ATC编码
    • L04AA13 leflunomide
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: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.
    ©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase