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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。

  1. 2025-06-03 · 欧委会决定

  2. 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 7产品信息 2其他 0

EPAR / 审评资料

  • 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

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  • Cholestagel : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2005-10-21

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产品信息

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。