法规知识库 · EMA 集中审评
Cholestagel
colesevelam (as hydrochloride) · EMEA/H/C/000512 · 已授权
获批上市许可
2004-03-09
欧委会决定日
2025-06-03
持有人 / 申请人
CHEPLAPHARM Arzneimittel GmbH
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:C10AC04
治疗领域:Hypercholesterolemia
药理分类:Lipid modifying agents
修订号:26 · 最新影响 PI 的程序:VR/0000267594
适应症(原文):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).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2025-06-03 · 欧委会决定
2004-03-09 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
- 打开官方文件 ↗
Cholestagel : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-06-03
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Cholestagel : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-03
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Cholestagel : EPAR - Risk management plan
rmp · 2024-09-06
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Cholestagel : EPAR - Summary for the public
overview · 2010-05-17
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Cholestagel-H-C-512-II-0014 : EPAR - Assessment Report - Variation
variation-report · 2010-05-05 · EMA/CHMP/259544/2010
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Cholestagel : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
- 打开官方文件 ↗
Cholestagel : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。