贝组替凡片 | China Drugs ListBelzutifan tablets | 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
- Welireg
- 企业
- Merck Sharp & Dohme B.V. (欧盟上市许可持有人)Merck Sharp & Dohme B.V. (EU authorization holder)
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 欧盟来源摘要：单药用于至少两线治疗后进展的成人晚期透明细胞肾细胞癌，既往治疗须包括PD-(L)1抑制剂及至少两种靶向VEGF的治疗。也用于患von Hippel-Lindau病的成人，在局部处理不适合时，治疗需要干预的相关局限性肾细胞癌、中枢神经系统血管母细胞瘤或胰腺神经内分泌肿瘤。European Union source summary: Monotherapy for adults with advanced clear-cell renal cell carcinoma progressing after at least two treatment lines that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies. Also for adults with von Hippel-Lindau disease requiring treatment for localized associated renal cell carcinoma, CNS hemangioblastomas or pancreatic neuroendocrine tumors when local procedures are unsuitable.
- 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/welireg-epar-product-information_en.pdf
- Welireg——欧盟官方产品资料Welireg — 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.
- Welireg——EMA评估和产品概述Welireg — 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.
- 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：