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

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