伊那利塞片 | China Drugs ListInavolisib 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
- Roche Pharma(Schweiz) AGRoche Pharma (Schweiz) AG
- 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
- 与哌柏西利和氟维司群联合,治疗内分泌治疗耐药(包括辅助内分泌治疗期间或之后复发)、PIK3CA突变、HR阳性、HER2阴性的局部晚期或转移性乳腺癌成人患者;治疗前须以获批或充分验证的方法确认PIK3CA突变。In combination with palbociclib and fulvestrant, for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer. Endocrine resistance includes recurrence during or after adjuvant endocrine therapy. Confirm the PIK3CA mutation before treatment using an approved or adequately validated method.
- 适应症来源与口径
- 2026-04-17
- 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。Complete official prescribing information obtained. Mainland China label.
- 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
- 限联合哌柏西利和氟维司群,用于内分泌治疗耐药(包括在辅助内分泌治疗期间或之后出现复发)、PIK3CA突变、激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的局部晚期或转移性乳腺癌成人患者。Limited to use with palbociclib and fulvestrant in adults with endocrine-resistant (including recurrence during or after adjuvant endocrine therapy), PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer.
- 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.