Basic Information
Praluent
Regulatory Information
EMEA/H/C/003882
September 23, 2015
July 23, 2015
24
December 10, 2024
Company Information
France
82 Avenue Raspail 94250 Gentilly
SANOFI WINTHROP INDUSTRIE
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular 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.
Overview Summary
Praluent is a medicine for lowering levels of fat in the blood. It is used to reduce fat levels in adults with primary hypercholesterolaemia (high levels of blood cholesterol without an identifiable cause, often resulting from the person’s genetic makeup) and mixed dyslipidaemia (abnormal levels of different fats in the blood, including cholesterol). It is also used in children from 8 years of age with heterozygous familial hypercholesterolaemia (high levels of blood cholesterol with a genetic cause that is inherited from one parent). It is also used to reduce the risk of heart problems and strokes in adults who have atherosclerotic cardiovascular disease (heart problems such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries). Praluent is used in combination with a statin or with a statin and other fat-lowering medicines. Praluent can also be used without a statin in patients who cannot take statins. Some patients are required to be on a low-fat diet. Praluent contains the active substance alirocumab.