Vanzacaftor/tezacaftor/deutivacaftor片 | China Drugs ListVanzacaftor / tezacaftor / deutivacaftor 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
- Alyftrek
- 企业
- Vertex Pharmaceuticals Incorporated
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 呼吸与过敏Respiratory & allergy
- 公开来源记录的适应症
- 美国：用于6岁及以上临床诊断为囊性纤维化的患者，要求至少有一种CFTR变异根据临床/体外证据对治疗有反应，或能产生CFTR蛋白。基因型未知时须通过FDA许可的基因检测确认。US: Cystic fibrosis in patients aged 6 years or older with a clinical diagnosis and at least one CFTR variant that is responsive on clinical/in-vitro evidence or produces CFTR protein. Confirm the genotype using an FDA-cleared genetic test if it is unknown.
- 适应症来源与口径
- 美国处方资料 修订于 2026年3月. 部分境外适应症；不确立中国批准范围。US prescribing information revised March 2026. 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
- 本次导入未独立核实中国批准、当地批准适应症及当前供应情况。Chinese approval, locally approved indications and current availability have not been independently verified in this import.
- 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.accessdata.fda.gov/drugsatfda_docs/label/2026/218730s001lbl.pdf
- Alyftrek——官方处方资料Alyftrek — official prescribing information
Official prescribing information · US prescribing information revised March 2026
已核查英文一手来源。此证据描述所引用的境外司法辖区情况，不能核实中国批准、适应症、报销或在售情况。English primary source reviewed. This evidence describes the cited overseas jurisdiction and does not verify Chinese approval, indications, reimbursement or market availability.
证据核查日期：