曲美替尼片 | China Drugs ListTrametinib 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。
其他
- 商品名
- Mekinist
- 企业
- Novartis Europharm Limited (欧盟上市许可持有人)Novartis Europharm Limited (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：用于成人及12岁及以上青少年BRAF V600突变、不可切除或转移性黑色素瘤，可单用或与达拉非尼联合。BRAF抑制剂治疗后进展者，单药尚未显示活性。与达拉非尼联合，用于该年龄组完全切除的III期BRAF V600突变黑色素瘤辅助治疗，以及成人晚期BRAF V600突变非小细胞肺癌。本摘要不确立中国批准的适应症范围。Selected EU indications: For BRAF V600-mutated unresectable or metastatic melanoma in adults and adolescents aged 12 years and older, alone or with dabrafenib. Monotherapy has not demonstrated activity after progression on a BRAF inhibitor. With dabrafenib, for adjuvant treatment of completely resected stage III BRAF V600-mutated melanoma in that age group, and adults with advanced BRAF V600-mutated non-small cell lung cancer. 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/mekinist
- Mekinist——EMA欧洲公开评估报告Mekinist — 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.
证据核查日期：