泽布替尼胶囊 | China Drugs ListZanubrutinib capsules | 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。
- 商品名
- 百悦泽 / BrukinsaBaiyueze / Brukinsa
- 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
- 本品单药适用于: 1)既往至少接受过一种治疗的套细胞淋巴瘤(MCL)成人患者。 2)慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)成人患者。 3)华氏巨球蛋白血症(WM)成人患者。 本品联合奥妥珠单抗,适用于: 既往接受过至少二线系统性治疗的复发或难治性滤泡性淋巴瘤(FL)成人患者。Monotherapy for: (1) adults with mantle cell lymphoma after at least one previous treatment; (2) adults with chronic lymphocytic leukemia or small lymphocytic lymphoma; (3) adults with Waldenstrom macroglobulinemia. In combination with obinutuzumab for adults with relapsed or refractory follicular lymphoma after at least two previous lines of systemic treatment.
- 适应症来源与口径
- 来源日期： 2025, 2026. 适应症转录自国家医保局公开的企业申报资料；不代表已核实完整的现行说明书。Source date(s): 2025, 2026. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label.
- 说明书信息局限
- 已取得完整官方药品说明书。 现有完整说明书来自海外辖区；尚未取得完整的中国现行说明书。中国适应症另由中国来源支持。Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
- 中国可获得性状态
- 已核实中国历史批准记录；尚未逐项核查每个产品目前是否持续上市销售。Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- 海外状态
- 英国: 已取得当地获批／上市公告及官方价格来源。每条价格记录注明适应症与日期；未全面核查其他市场。United Kingdom: local approval / launch announcements and official price sources obtained. Indications and dates are specified in each price record; other markets not exhaustively reviewed.
- 医保分类
- 已纳入国家医保（乙类）Included in national insurance (Category B)
- 医保版本
- 2025版；2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保限制
- 限：1.既往至少接受过一种治疗的成人套细胞淋巴瘤(MCL)患者；2.成人慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)患者；3.成人华氏巨球蛋白血症(WM)患者；4.联合奥妥珠单抗用于既往接受过至少二线系统性治疗的复发或难治性滤泡性淋巴瘤(FL)成人患者。Restricted to: (1) adults with mantle cell lymphoma after at least one previous treatment; (2) adults with CLL/SLL; (3) adults with Waldenstrom macroglobulinemia; (4) use with obinutuzumab for adults with relapsed or refractory follicular lymphoma after at least two previous lines of systemic treatment.
- 医保期限
- 2026-01-01 至 2027-12-312026-01-01 to 2027-12-31
- 医保核查说明
- 按成分／剂型名称精确或标准化匹配。报销仍取决于剂型及目录所列支付限制。Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.