特立妥单抗注射液 | China Drugs ListTeclistamab solution for injection | 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
- Tecvayli
- 企业
- Janssen-Cilag International NV (欧盟上市许可持有人)Janssen-Cilag International NV (EU authorization holder)
- 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
- 欧盟：与达雷妥尤单抗联合，用于至少一种既往治疗后的成人复发或难治性多发性骨髓瘤。单药用于接受至少三种治疗（包括免疫调节剂、蛋白酶体抑制剂及抗CD38抗体）后、末次治疗期间进展的成人复发且难治性疾病。EU: With daratumumab for adults with relapsed or refractory multiple myeloma after at least one prior therapy. Used alone for adults with relapsed and refractory disease progressing on the last treatment after at least three therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
- 适应症来源与口径
- 欧盟产品资料 更新于 2026-08-27. 部分境外适应症；不确立中国批准范围。EU product information updated 2026-08-27. 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
- 本次导入未独立核实中国批准、当地批准适应症及当前供应情况。Chinese approval, locally approved indications and current availability have not been independently verified in this import.
- 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/tecvayli-epar-product-information_en.pdf
- Tecvayli——官方处方资料Tecvayli — official prescribing information
Official prescribing information · EU product information updated 2026-08-27
已核查英文一手来源。此证据描述所引用的境外司法辖区情况，不能核实中国批准、适应症、报销或在售情况。English primary source reviewed. This evidence describes the cited overseas jurisdiction and does not verify Chinese approval, indications, reimbursement or market availability.
证据核查日期：