欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Trevaclyn
适用类别Human
治疗领域Dyslipidemias
通用名/非专利名称laropiprant;nicotinic acid
活性成分laropiprant;nicotinic acid
产品号EMEA/H/C/000897
患者安全信息No
许可状态Withdrawn
ATC编码C10AD52
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2008/07/03
上市许可开发者/申请人/持有人Merck Sharp Dohme Ltd
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2013/04/10
修订号11
治疗适应症Trevaclyn 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). Trevaclyn 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 Trevaclyn.
适用物种
兽用药物ATC编码
首次发布日期2013/04/10
最后更新日期2013/05/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/trevaclyn-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/trevaclyn
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