芦沃美替尼片 | China Drugs ListLuvometinib 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。
- 企业
- 上海复星医药产业发展有限公司Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.
- 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
- 1. 用于朗格汉斯细胞组织细胞增生症（LCH）或组织细胞肿瘤成人患者。 2. 用于2岁及以上伴有症状、无法手术的丛状神经纤维瘤（PN）的Ⅰ型神经纤维瘤病（NF1）儿童及青少年患者。 3. 用于2岁及以上经系统治疗后复发或难治的LCH儿童及青少年患者。 4. 用于伴有症状、无法手术的PN的NF1成人患者。后两项依据2026年厂家获批公告补充，官网完整说明书仍为2025年初始版。(1) Adults with Langerhans cell histiocytosis (LCH) or histiocytic neoplasms. (2) Children and adolescents aged 2 years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PN). (3) Children and adolescents aged 2 years and older with relapsed or refractory LCH after systemic treatment. (4) Adults with NF1 and symptomatic, inoperable PN. The last two uses were added from the manufacturer's 2026 approval announcements; the complete label on its website remains the initial 2025 version.
- 适应症来源与口径
- 来源日期： 2026-09-03, 2025. 生产商面向中国大陆的药品说明书。 历史版本说明书；可能未包括后续变更。Source date(s): 2026-09-03, 2025. Manufacturer prescribing information for Mainland China. Historical label; subsequent changes may not be included.
- 说明书信息局限
- 已取得完整官方药品说明书。 中国大陆说明书。 完整文件为较旧版本；较新适应症由另行公告或申报资料支持。 2026年新增适应症由生产商获批公告支持。Complete official prescribing information obtained. Mainland China label. The full document is an older version; newer indications are supported by separate announcements or submissions. Additional 2026 indications are supported by manufacturer approval announcements.
- 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
- 待逐一核查各市场。Market-by-market verification pending.
- 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：1.2岁及2岁以上伴有症状、无法手术的丛状神经纤维瘤(PN)的I型神经纤维瘤病(NF1)儿童及青少年患者；2.朗格汉斯细胞组织细胞增生症(LCH)和组织细胞肿瘤成人患者。Restricted to: (1) children and adolescents aged 2 years and older with NF1 and symptomatic, inoperable PN; (2) adults with LCH or histiocytic neoplasms.
- 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.