普拉替尼胶囊 | China Drugs ListPralsetinib 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。
其他
- 商品名
- Gavreto
- 企业
- Rigel Pharmaceuticals, Inc. (美国说明书)Rigel Pharmaceuticals, Inc. (US label)
- 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
- 美国处方资料：用于经FDA批准检测方法确认的成人转移性RET融合阳性非小细胞肺癌。也用于成人及12岁及以上儿童需要全身治疗的晚期或转移性RET融合阳性甲状腺癌，适用时须对放射性碘难治；该甲状腺癌适应症为加速批准。这些美国适应症不确立中国批准范围。欧盟许可于2024年10月因商业原因撤销。US prescribing information: adults with metastatic RET fusion-positive non-small cell lung cancer identified by an FDA-approved test. Also adults and children aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy and refractory to radioactive iodine when appropriate; this thyroid indication has accelerated approval. These US indications do not establish Chinese approval. The EU authorization was withdrawn in October 2024 for commercial reasons.
- 适应症来源与口径
- 修订于 12/2025； 生效于 2025-12-30. 部分境外适应症；不确立中国批准范围。Revised 12/2025; effective 2025-12-30. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 中国可获得性状态
- 本次英文来源核查未独立核实中国批准、现行中国适应症及持续在售情况。Chinese approval, current Chinese indications and continuous market availability were not independently verified in this English-source review.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=16edd46e-28b8-f06d-e063-6394a90ae31b&type=display
- Gavreto——DailyMed所载Rigel完整美国处方资料Gavreto — Rigel full US prescribing information on DailyMed
Official prescribing information · Revised 12/2025; effective 2025-12-30
已打开美国厂商完整说明书，包括适应症和机制章节。甲状腺癌适应症为加速批准；未据此推断存在甲状腺髓样癌适应症。Complete US manufacturer label opened, including indication and mechanism sections. Thyroid indication is accelerated approval; no medullary thyroid cancer indication is inferred.
- Gavreto——EMA许可撤销通知Gavreto — EMA withdrawal notice
Regulatory authorization status · Withdrawal 2024-10-24; page updated 2025-01-17
欧盟许可因商业原因应持有人申请撤销；历史欧盟产品资料不作为当前许可展示。EU authorization withdrawn at the holder request for commercial reasons; historical EU product information is not presented as a current authorization.
证据核查日期：