欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cholestagel
适用类别Human
治疗领域Hypercholesterolemia
通用名/非专利名称colesevelam
活性成分colesevelam (as hydrochloride)
产品号EMEA/H/C/000512
患者安全信息No
许可状态Authorised
ATC编码C10AC04
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2004/03/09
上市许可开发者/申请人/持有人CHEPLAPHARM Arzneimittel GmbH
人用药物治疗学分组Lipid modifying agents
兽用药物治疗学分组
欧盟委员会决定日期2025/06/03
修订号26
治疗适应症Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
适用物种
兽用药物ATC编码
首次发布日期2017/04/28
最后更新日期2025/06/03
产品说明书https://www.ema.europa.eu/en/documents/product-information/cholestagel-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cholestagel
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