欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号AT/H/0872/001
药品名称Melerio 50 mg Powder and Solvent for Solution for Injection/Infusion
活性成分
    • melphalan 50.0 mg
剂型Powder and solvent for solution for injection/infusion
上市许可持有人ELC group s.r.o. Karolinska 650/1, Karlin 18600 Prague 8 Czech Republic
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Hungary (HU)
      Eriolan
    • Italy (IT)
    • Poland (PL)
      Eriolan
    • Spain (ES)
许可日期2021/06/23
最近更新日期2021/07/14
药物ATC编码
    • L01AA03 melphalan
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：2.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided could allow to conclude on a positive benefit-risk balance if the points for clarification identified were solved.
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