欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3766/001
药品名称Clofarabine SUN
活性成分
    • CLOFARABINE 1.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人SUN Pharmaceutical Industries Europe B.V. Polarisavenue 87 Hoofddorp The Netherlands
参考成员国 - 产品名称Netherlands (NL)
Clofarabine SUN 1 mg/ml concentraat voor oplossing voor infusie
互认成员国 - 产品名称
    • France (FR)
    • Germany (DE)
      Clofarabin SUN 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
    • Italy (IT)
    • Spain (ES)
    • United Kingdom (GB)
许可日期2017/09/05
最近更新日期2017/09/19
药物ATC编码
    • L01BB06 clofarabine
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: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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