索磷布韦片 | China Drugs ListSofosbuvir 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
- Sovaldi
- 企业
- Gilead Sciences Ireland UC (欧盟上市许可持有人)Gilead Sciences Ireland UC (EU authorization holder)
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 感染性疾病Infectious diseases
- 公开来源记录的适应症
- 欧盟：与其他抗病毒药物联合，用于成人及3岁及以上儿童慢性丙型肝炎。方案和疗程取决于病毒基因型及临床情况；概述规定儿童适用于基因2型或3型。本单一成分产品与索磷布韦/维帕他韦复方不同。EU: Chronic hepatitis C in adults and children aged 3 years or older, in combination with other antiviral medicines. Regimen and duration depend on viral genotype and clinical circumstances; the overview specifies genotypes 2 or 3 for children. This single-ingredient product is distinct from sofosbuvir/velpatasvir.
- 适应症来源与口径
- EMA英文EPAR概述和产品详情 查阅于 2026-11-02. 部分境外适应症；不确立中国批准范围。English EMA EPAR overview and product details 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.ema.europa.eu/en/medicines/human/EPAR/sovaldi
- Sovaldi——EMA药品概述和产品详情Sovaldi — EMA medicine overview and product details
Regulatory medicine overview · English EMA EPAR overview and product details accessed 2026-11-02
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：