欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5654/001
药品名称isoPROtrace-11 Kit for radiopharmaceutical preparation 10 µg
活性成分
    • gallium Ga 68 PSMA 11 10.0 µg
剂型Kit for radiopharmaceutical preparation
上市许可持有人Billev Pharma ApS Slotsmarken 10 2970 Hoersholm Hovedstaden Denmark
参考成员国 - 产品名称Netherlands (NL)
isoPROtrace-11 10 µg, kit voor radiofarmaceutisch preparaat
互认成员国 - 产品名称
    • Sweden (SE)
    • Cyprus (CY)
      isoPROtrace Kit for radiopharmaceutical preparation 10 µ
    • Malta (MT)
    • Denmark (DK)
      Isoprotrace
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Greece (GR)
    • Germany (DE)
      isoPROtrace-11 10 μg Kit für ein radioaktives Arzneimittel
许可日期2024/01/10
最近更新日期2025/02/10
药物ATC编码
    • V09IX14 gallium (68Ga) gozetotide
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
©2006-2025 Drugfuture->European Union HMA Authorisation of Medicines DataBase