氟唑帕利胶囊 | China Drugs ListFluzoparib 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。
- 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单药治疗具有胚系BRCA突变（gBRCA）、既往接受过二线及以上化疗的铂敏感复发性卵巢癌、输卵管癌或原发性腹膜癌；②铂敏感复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者，在含铂化疗后完全缓解或部分缓解时的维持治疗；③晚期上述三类癌症成人患者，在一线含铂化疗后完全缓解或部分缓解时的维持治疗；④单药或联合甲磺酸阿帕替尼，治疗既往在新辅助、辅助或转移性阶段接受过化疗的gBRCA突变、HER2阴性转移性乳腺癌成人患者；HR阳性患者须既往接受过内分泌治疗，或不适合内分泌治疗。(1) Monotherapy for platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancer with a germline BRCA mutation after at least two prior lines of chemotherapy. (2) Maintenance treatment for adults with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer after a complete or partial response to platinum-based chemotherapy. (3) Maintenance treatment for adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer after a complete or partial response to first-line platinum-based chemotherapy. (4) Alone or with apatinib mesylate for adults with germline BRCA-mutated, HER2-negative metastatic breast cancer who received chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with HR-positive breast cancer must previously have received endocrine therapy or be considered unsuitable for it.
- 适应症来源与口径
- 2025-12-26
- 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。 生产商原始页面图像已按顺序保存。Complete official prescribing information obtained. Mainland China label. Original manufacturer page images have been preserved in order.
- 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.既往经过二线及以上化疗的伴有胚系BRCA突变(gBRCAm)的铂敏感复发性卵巢癌、输卵管癌或原发性腹膜癌的患者；2.铂敏感的复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在含铂化疗达到完全缓解或部分缓解后的维持治疗；3.晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在一线含铂化疗达到完全缓解或部分缓解后的维持治疗；4.单药或联合甲磺酸阿帕替尼用于新辅助、辅助或转移阶段接受过化疗治疗的伴有胚系BRCA突变(gBRCAm)的人表皮生长因子受体(HER2)阴性转移性乳腺癌成年患者。激素受体(HR)阳性乳腺癌患者既往需接受过内分泌治疗或被认为不适合接受内分泌治疗。Restricted to: (1) Monotherapy for platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancer with a germline BRCA mutation after at least two prior lines of chemotherapy. (2) Maintenance treatment for adults with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer after a complete or partial response to platinum-based chemotherapy. (3) Maintenance treatment for adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer after a complete or partial response to first-line platinum-based chemotherapy. (4) Alone or with apatinib mesylate for adults with germline BRCA-mutated, HER2-negative metastatic breast cancer who received chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with HR-positive breast cancer must previously have received endocrine therapy or be considered unsuitable for it.
- 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.