欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/0737/002
药品名称Colistimethat-Natrium Carinopharm 2 Mio I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
活性成分
    • colistimethate sodium 2.0 million IU
剂型-
上市许可持有人Carinopharm GmbH Bahnhofstr. 18 31008 Elze Germany
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Germany (DE)
      Colistimethat-Natrium Carinopharm 2 Mio I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
    • Italy (IT)
许可日期2019/12/09
最近更新日期2020/01/16
药物ATC编码
    • J01XB01 colistin
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