依库珠单抗注射液 | China Drugs ListEculizumab concentrate for infusion | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
其他
- 商品名
- Soliris
- 企业
- Alexion Europe SAS (欧盟上市许可持有人)Alexion Europe SAS (EU authorization holder)
- 药品类型
- 生物药Biologic
- 治疗领域
- 非恶性血液疾病Non-malignant blood disorders
- 公开来源记录的适应症
- 欧盟来源摘要：用于成人和儿童阵发性睡眠性血红蛋白尿症或非典型溶血性尿毒综合征；至少6岁的AChR抗体阳性患者难治性全身型重症肌无力；以及成人复发性AQP4抗体阳性视神经脊髓炎谱系疾病。European Union source summary: For adults and children with paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome; refractory generalized myasthenia gravis in AChR-antibody-positive patients aged at least 6 years; and relapsing AQP4-antibody-positive neuromyelitis optica spectrum disorder in adults.
- 适应症来源与口径
- 欧盟产品资料 查阅于 2026年11月2日； 未单独提取确切修订日期. 部分境外适应症；不确立中国批准范围。European Union product information accessed 2 November 2026; exact revision date not separately extracted.. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 中国可获得性状态
- 本次英文来源核查未独立核实中国批准、现行批准适应症及持续在售情况。Chinese approval, current approved indications and continuous market availability have not been independently verified in this English-source review.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf
- Soliris——欧盟官方产品资料Soliris — official European Union product information
Official prescribing information · European Union product information accessed 2 November 2026; exact revision date not separately extracted.
已打开完整官方PDF，并核对药品身份及相关适应症文字。此境外来源不确立中国批准范围。Full official PDF opened; medicine identity and relevant indication text checked. This overseas source does not establish the Chinese approved scope.
- Soliris——EMA评估和产品概述Soliris — EMA assessment and product overview
Regulatory product overview · Accessed 2 November 2026
英文监管资料；所列许可持有人对应欧盟产品，并非中国仿制药或生物类似药。English regulatory reference; authorization holder is identified for the EU product, not a Chinese generic or biosimilar.
- FDA NDC目录——包装参考FDA NDC directory — packaging reference
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
- 得克萨斯州卫生服务部（DSHS）——2026年度WAC报告Texas DSHS — 2026 annual WAC report
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
- 东莞东华医院——公示价格Dongguan Donghua Hospital — public prices
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
证据核查日期：