欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
适用类别Human
治疗领域Neuroblastoma
通用名/非专利名称dinutuximab beta
活性成分Dinutuximab beta
产品号EMEA/H/C/003918
患者安全信息No
许可状态Authorised
ATC编码L01FX06
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形Yes
是否加速审评No
是否罕用药Yes
上市许可日期2017/05/08
上市许可开发者/申请人/持有人Recordati Netherlands B.V.
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2017/03/23
欧盟委员会决定日期2025/11/26
修订号18
治疗适应症Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin 2 (IL 2).
适用物种
兽用药物ATC编码
首次发布日期2018/03/05
最后更新日期2025/11/26
产品说明书https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/qarziba
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