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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
- Darzalex
- 企业
- Janssen Biotech, Inc.
- 药品类型
- 生物药Biologic
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 美国成人多发性骨髓瘤用途包括新诊断或既往治疗疾病的特定多药方案，具体根据移植资格和治疗史选择。例如，与来那度胺及地塞米松联合，用于不适合移植的新诊断患者，或既往接受至少一种治疗的复发/难治患者。单药治疗要求既往接受至少三线治疗且其中包括蛋白酶体抑制剂和免疫调节剂，或对这两类药物均耐药。其他批准的联合方案见所链接的说明书。US use in adult multiple myeloma includes specified multidrug regimens for newly diagnosed or previously treated disease, selected according to transplant eligibility and treatment history. Examples include lenalidomide plus dexamethasone for newly diagnosed transplant-ineligible patients or relapsed/refractory patients after at least one prior therapy. Monotherapy requires at least three prior lines including a proteasome inhibitor and an immunomodulatory agent, or resistance to both classes. The linked label gives the other approved combinations.
- 适应症来源与口径
- 美国处方资料 修订于 2026年6月. 部分境外适应症；不确立中国批准范围。US prescribing information revised June 2026. 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详情及当前供应情况。Chinese approval details and current 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.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
- Darzalex——美国处方资料Darzalex — US prescribing information
Official prescribing information · US prescribing information revised June 2026
已于2026年11月2日打开英文一手来源。本摘要列出部分美国适应症，并非现行中国批准范围的全集。English primary source opened on 2 November 2026. The summary lists selected US indications, not the complete current Chinese approved scope.
- 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.
- 深圳新风和睦家医院——公示价格Shenzhen New Frontier United Family 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：