塞普替尼胶囊 | China Drugs ListSelpercatinib 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
- Retevmo / Retsevmo
- 企业
- Eli Lilly and Company （美国）; Eli Lilly Nederland B.V. (欧盟上市许可持有人)Eli Lilly and Company (US); Eli Lilly Nederland B.V. (EU authorization holder)
- 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
- 欧盟部分适应症：单药用于既往未接受RET抑制剂治疗的成人晚期RET融合阳性非小细胞肺癌。成人及至少2岁儿童的特定用途包括晚期RET融合阳性甲状腺癌（适用时须对放射性碘难治）、晚期RET突变甲状腺髓样癌，以及非RET治疗选择获益有限或已用尽的晚期RET融合阳性实体瘤。本摘要不确立中国批准的适应症范围。Selected EU indications: Monotherapy for adults with advanced RET fusion-positive non-small cell lung cancer without previous RET-inhibitor treatment. For adults and children aged at least 2 years, specified uses include advanced RET fusion-positive thyroid cancer refractory to radioactive iodine when appropriate, advanced RET-mutant medullary thyroid cancer, and advanced RET fusion-positive solid tumors with limited benefit from or exhaustion of non-RET treatment options. This summary does not establish the approved indications in China.
- 适应症来源与口径
- 网页 查阅于 2026-11-02. 部分境外适应症；不确立中国批准范围。Web page accessed 2026-11-02. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接监管机构产品资料／批准证据；本次核查尚未核实完整的现行处方资料文件。Regulatory product information / approval evidence is linked; a complete current prescribing-information document has not been verified in this review.
- 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.ema.europa.eu/en/medicines/human/EPAR/retsevmo
- Retevmo / Retsevmo——EMA欧洲公开评估报告Retevmo / Retsevmo — EMA European public assessment report
Regulatory medicine overview · Web page accessed 2026-11-02
已打开并核查英文监管一手来源。此处报告部分欧盟适应症及欧盟许可持有人；不作为中国批准证据。English primary regulatory source opened and reviewed. Selected EU indications and the EU authorization holder are reported; this is not evidence of Chinese approval.
- FDA对塞普替尼治疗RET融合阳性实体瘤给予常规批准FDA traditional approval of selpercatinib for RET fusion-positive solid tumors
Regulatory approval announcement · 2026-07-14
已打开的FDA来源确认美国品牌Retevmo及礼来。上文主要摘要采用另行链接的欧盟适用范围。Opened FDA source confirms the US brand Retevmo and Eli Lilly. The main summary above follows the separately linked EU scope.
证据核查日期：