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法规知识库 · EMA 集中审评

Pelzont

laropiprant;nicotinic acid · EMEA/H/C/000903 · 已撤市

获批上市许可

2008-07-03

欧委会决定日

2013-04-10

持有人 / 申请人

Merck Sharp Dohme Ltd

终止日期字段

2013-04-10

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:C10AD52

治疗领域:Dyslipidemias

药理分类:Lipid modifying agents

修订号:11 · 最新影响 PI 的程序:A20/0038

适应症(原文):Pelzont is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL)cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Pelzont.

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. 2013-04-10 · 欧委会决定

  2. 2013-04-10 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  3. 2008-07-03 · 获批上市许可

说明书、EPAR 与其他文件

仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。

EPAR / 审评资料 5产品信息 2其他 0

EPAR / 审评资料

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。