法规知识库 · EMA 集中审评
Tredaptive
laropiprant;nicotinic acid · EMEA/H/C/000889 · 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):Tredaptive 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). Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-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 Tredaptive.
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。
2013-04-10 · 欧委会决定
2013-04-10 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
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
- 打开官方文件 ↗
Tredaptive-H-C-889-A20-37 : EPAR - Assessment Report - Article 20
variation-report · 2013-03-22 · EMA/45910/2013
- 打开官方文件 ↗
Tredaptive : EPAR - Scientific Conclusion
scientific-conclusion · 2013-03-22
- 打开官方文件 ↗
Tredaptive : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2013-03-22
- 打开官方文件 ↗
Tredaptive : EPAR - Public assessment report
assessment-report · 2008-07-11
- 打开官方文件 ↗
Tredaptive : EPAR - Summary for the public
overview · 2008-07-11
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。