欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Repatha
适用类别Human
治疗领域Dyslipidemias;Hypercholesterolemia
通用名/非专利名称evolocumab
活性成分Evolocumab
产品号EMEA/H/C/003766
患者安全信息No
许可状态Authorised
ATC编码C10AX13
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2015/07/17
上市许可开发者/申请人/持有人Amgen Europe B.V.
人用药物治疗学分组Lipid modifying agents
兽用药物治疗学分组
审评意见日期2015/05/20
欧盟委员会决定日期2025/12/12
修订号27
治疗适应症Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
适用物种
兽用药物ATC编码
首次发布日期2018/06/04
最后更新日期2025/12/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/repatha-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/repatha
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