达拉非尼胶囊 | China Drugs ListDabrafenib 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
- Tafinlar
- 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，可单用或与曲美替尼联合。与曲美替尼联合，也用于该年龄组III期BRAF V600突变黑色素瘤完全切除后的辅助治疗，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 trametinib. With trametinib, for adjuvant treatment after complete resection of stage III BRAF V600-mutated melanoma in that age group, and for 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/tafinlar
- Tafinlar——EMA欧洲公开评估报告Tafinlar — 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：