欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/7350/001
药品名称Sugammadex Pharmabide
活性成分
    • Sugammadex sodium 100.0 mg/ml
剂型Solution for injection
上市许可持有人Pharmabide Ltd. Pentelis Avenue 31 152 35 Vrilissia Greece
参考成员国 - 产品名称Germany (DE)
Sugammadex Pharmabide 100 mg/ml Injektionslösung
互认成员国 - 产品名称
    • Austria (AT)
许可日期2023/09/08
最近更新日期2023/09/20
药物ATC编码
    • V03AB35 sugammadex
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: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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