库莱韦拜单抗注射液 | China Drugs ListClulevibart 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。
- 企业
- 瑞阳（山东）生物制药Reyoung (Shandong) Biopharmaceutical
- 药品类型
- 生物药Biologic
- 治疗领域
- 感染性疾病Infectious diseases
- 公开来源记录的适应症
- 第一个RSV流行季、胎龄≥35周新生儿及婴儿预防RSV下呼吸道感染；不包括患慢性肺病或有临床意义先天性呼吸道异常的儿童。Prevention of respiratory syncytial virus (RSV) lower respiratory tract infection during the first RSV season in neonates and infants born at a gestational age of at least 35 weeks. Excludes children with chronic lung disease or clinically significant congenital respiratory tract abnormalities.
- 适应症来源与口径
- 来源日期： 2026. 适应症反映所引用的历史批准范围，不是截至2026年的完整适应症。Source date(s): 2026. Indications reflect the cited historical approval, not the complete indication set as of 2026.
- 说明书信息局限
- 尚未取得可核实的完整药品说明书。现有批准记录或国家医保局申报资料支持所示适应症；最新完整范围尚待确认。A verifiable complete prescribing-information document has not yet been obtained. Available approval records or NHSA submissions support the indications shown; the latest full scope needs confirmation.
- 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
- 2025国家医保目录未匹配；待人工复核Not matched in the 2025 national list; manual review pending
- 医保版本
- 2025版；2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保核查说明
- 未在提取的目录中匹配到，并不证明被排除。复方制剂仍需人工复核。No match in the extracted directory is not proof of exclusion. Compound formulations still require manual review.