欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号IE/H/0757/001
药品名称Topotecan 1mg/ml Concentrate for Solution for Infusion
活性成分
    • Topotecan hydrochloride 1.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人ACCORD HEALTHCARE LIMITED SAGE HOUSE 319 PINNER ROAD HARROW MIDDLESEX HA1 4HF UNITED KINGDOM
参考成员国 - 产品名称Ireland (IE)
互认成员国 - 产品名称
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
      PL 20075/0307 - 0014
    • Germany (DE)
      Topotecan Accord 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
    • Denmark (DK)
      Topotecan Accord
    • Belgium (BE)
    • Netherlands (NL)
      Topotecan Accord 1 mg/ml, concentraat voor oplossing voor infusie
    • Austria (AT)
      Topotecan Accord 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
      Topotecan ACHL 1 mg/ml koncentrāts infūziju šķīduma pagatavošanai
    • Lithuania (LT)
      Topotecan Accord 1 mg/ml koncentratas infuziniam tirpalui
    • Estonia (EE)
      TOPOTECAN ACCORD 1MG/ML
    • Hungary (HU)
      TOPOTECAN ACCORD 1 mg/ml koncentrátum oldatos infúzióhoz
    • Bulgaria (BG)
      Topotecan Accord
    • Cyprus (CY)
      TOPOTECAN ACCORD 1mg/ml CON FOR SOL FOR INF
    • Czechia (CZ)
      Topotecan Accord 1 mg/ml Koncentrát pro Infuzní roztok
    • Romania (RO)
      Topotecan Accord 1 mg/ml concentrat pentru solutie perfuzabila
    • Slovakia (SK)
    • Slovenia (SI)
      Topotekan Accord 1 mg/ml koncentrat za raztopino za infundiranje
许可日期2012/02/28
最近更新日期2025/01/10
药物ATC编码
    • L01XX17 topotecan
申请类型
  • TypeLevel1:[not specified]
  • TypeLevel2:[not specified]
  • TypeLevel3:[not specified]
  • TypeLevel4:[not specified]
  • TypeLevel5:[not specified]
附件文件下载
    市场状态Positive
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