重组人血小板生成素注射液 | China Drugs ListRecombinant human thrombopoietin 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。
- 商品名
- TPIAO
- 企业
- 三生制药3SBio
- 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
- 1、本品适用于治疗实体瘤化疗后所致的血小板减少症,适用对象为血小板低于50×10^9/L且医生认为有必要升高血小板治疗的患者。 2、本品适用于原发免疫性血小板减少症(ITP)的辅助治疗,适用对象为血小板低于20×10^9/L的糖皮质激素治疗无效(包括初始治疗无效、或有效后复发而再度治疗无效)但未接受脾切除治疗的成人患者。 3、本品适用于既往对糖皮质激素、免疫球蛋白等治疗反应不佳但未接受脾切除治疗的6岁及以上儿童慢性原发免疫性血小板减少症(ITP)患者,使血小板计数升高并减少或防止出血。 针对ITP患者,本品仅用于因血小板减少和临床条件导致出血风险增加的ITP患者,不应用于试图使血小板计数升至正常数值的目的。(1) Thrombocytopenia after chemotherapy for solid tumors, when the platelet count is below 50 x 10^9/L and the physician considers treatment to raise platelets necessary. (2) Adjunctive treatment of primary immune thrombocytopenia (ITP) in adults with a platelet count below 20 x 10^9/L who have not undergone splenectomy and whose glucocorticoid treatment was ineffective, including initial nonresponse or relapse after a response followed by failure of retreatment. (3) To raise platelets and reduce or prevent bleeding in children aged 6 years and older with chronic primary ITP who have responded poorly to treatments such as glucocorticoids or immunoglobulin and have not undergone splenectomy. In ITP, use is limited to patients whose thrombocytopenia and clinical condition increase their risk of bleeding; it must not be used merely to normalize the platelet count.
- 适应症来源与口径
- 来源日期： 2024, 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): 2024, 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
- 适应症已与官方公开申报资料核对。尚未取得完整原始说明书。Indications checked against an official public submission. The full original prescribing information is still unavailable.
- 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
- 限实体瘤化疗后所致的血小板减少症或原发免疫性血小板减少症(ITP)。Restricted to thrombocytopenia after chemotherapy for solid tumors or primary immune thrombocytopenia (ITP).
- 医保期限
- 2025-01-01 至 2026-12-312025-01-01 to 2026-12-31
- 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.