盐酸阿曲生坦片 | China Drugs ListAtrasentan hydrochloride 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。
- 企业
- Novartis PharmaSchweiz AGNovartis Pharma Schweiz AG
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肾脏疾病Kidney diseases
- 公开来源记录的适应症
- 本品适用于降低有疾病快速进展风险的原发性免疫球蛋白A肾病（IgA肾病）成人患者的蛋白尿。一般来说，这类患者的尿蛋白肌酐比值（UPCR）≥ 1.5 g/g。 该中国适应症为基于降低蛋白尿的附条件批准；尚未确定是否减缓肾功能下降，后续批准取决于确证性试验的临床获益。Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgA nephropathy) at risk of rapid disease progression, generally those with a urine protein-to-creatinine ratio (UPCR) >=1.5 g/g. This Chinese indication has conditional approval based on proteinuria reduction. Whether it slows kidney function decline has not been established, and further approval depends on clinical benefit in a confirmatory trial.
- 适应症来源与口径
- 来源日期： 2025, 2026. 适应症反映所引用的历史批准范围，不是截至2026年的完整适应症。Source date(s): 2025, 2026. Indications reflect the cited historical approval, not the complete indication set as of 2026.
- 说明书信息局限
- 已取得完整官方药品说明书。 现有完整说明书来自海外辖区；尚未取得完整的中国现行说明书。中国适应症另由中国来源支持。Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
- 中国可获得性状态
- 已核实中国历史批准记录；尚未逐项核查每个产品目前是否持续上市销售。Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- 海外状态
- 待逐一核查各市场。Market-by-market verification pending.
- 医保分类
- 2025国家医保目录未匹配；待人工复核Not matched in the 2025 national list; manual review pending
- 医保版本
- 2025版；2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保核查说明
- 未在提取的目录中匹配到，并不证明被排除。复方制剂仍需人工复核。No match in the extracted directory is not proof of exclusion. Compound formulations still require manual review.