法规知识库 · EMA 集中审评
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta · EMEA/H/C/003918 · 已授权
获批上市许可
2017-05-08
欧委会决定日
2026-10-16
持有人 / 申请人
Recordati Netherlands B.V.
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01FX06
治疗领域:Neuroblastoma
药理分类:Antineoplastic agents
修订号:19 · 最新影响 PI 的程序:VR/0000316241
适应症(原文):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).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2026-10-16 · 欧委会决定
2017-05-08 · 获批上市许可
2017-03-23 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Qarziba: EPAR - Risk management plan
rmp · 2026-10-29
- 打开官方文件 ↗
Qarziba: EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-10-29 · EMADOC-1700519818-3433717
- 打开官方文件 ↗
Qarziba : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-29
- 打开官方文件 ↗
Qarziba : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2023-10-27
- 打开官方文件 ↗
Qarziba: EPAR - Summary for the public
overview · 2018-07-31
- 打开官方文件 ↗
Dinutuximab beta Apeiron : EPAR - Public assessment report
assessment-report · 2017-05-15 · EMA/263814/2017
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。