盐酸伊普可泮胶囊 | China Drugs ListIptacopan hydrochloride 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。
- 企业
- Novartis PharmaSchweiz AGNovartis Pharma Schweiz AG
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 非恶性血液疾病Non-malignant blood disorders
- 公开来源记录的适应症
- 本品适用于治疗: 1阵发性睡眠性血红蛋白尿症(PNH)成人患者。 2C3肾小球病(C3G)成人患者,以降低蛋白尿。 【中国2025年9月新增】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)成人患者的蛋白尿水平,为中国附条件批准。美国2026年7月“减缓IgAN肾功能下降”常规批准未直接迁移为中国适应症。1. Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 2. Treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria. Added in China in September 2025: Reduction of proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression; this Chinese indication has conditional approval. The July 2026 US regular approval for slowing kidney function decline in IgA nephropathy has not been treated as an approved Chinese indication.
- 适应症来源与口径
- 来源日期: 2025, 2026, 2026-07-24. 适应症转录自国家医保局公开的企业申报资料;不代表已核实完整的现行说明书。 新增适应症可能由较新的公告或申报资料支持,而非旧版完整说明书;请查看适应症来源。Source date(s): 2025, 2026, 2026-07-24. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
- 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
- 日本, 英国: 已取得当地获批/上市公告及官方价格来源。每条价格记录注明适应症与日期;未全面核查其他市场。Japan, United Kingdom: local approval / launch announcements and official price sources obtained. Indications and dates are specified in each price record; other markets not exhaustively reviewed.
- 医保分类
- 已纳入国家医保(乙类)Included in national insurance (Category B)
- 医保版本
- 2025版;2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保限制
- 限:1.阵发性睡眠性血红蛋白尿症(PNH)成人患者;2.C3肾小球病(C3G)成人患者。Limited to: 1. Adults with PNH. 2. Adults with C3G.
- 医保期限
- 2026-01-01 至 2026-12-312026-01-01 to 2026-12-31
- 医保核查说明
- 按成分/剂型名称精确或标准化匹配。报销仍取决于剂型及目录所列支付限制。Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.
来源
- https://www.cnpharm.com/upload/resources/file/2025/03/18/170990.pdf
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.nhsa.gov.cn/attach/Ypsn2025/YPSN202500239/YPSN202500239.pdf
- https://www.novartis.com.cn/news/nuohuayansuanyipukepanjiaonanghuomeiguofdachangguipizhunchengweishougeqiemuqianweiyihuopiyongyujianhuanyuanfaxingiganshengongnengxiajiangdebutiyizhiji