Praluent

RSS

alirocumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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 to reduce the risk of heart problems and strokes in patients 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 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.

It contains the active substance alirocumab.

This EPAR was last updated on 13/11/2019

Authorisation details

Product details
Name
Praluent
Agency product number
EMEA/H/C/003882
Active substance
Alirocumab
International non-proprietary name (INN) or common name
alirocumab
Therapeutic area (MeSH)
Dyslipidemias
Anatomical therapeutic chemical (ATC) code
C10AX14
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
sanofi-aventis groupe
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
23/09/2015
Contact address

54 rue La Boetie
75008 Paris
France

Product information

31/10/2019 Praluent - EMEA/H/C/003882 - IB/0047/G

Contents

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Pharmacotherapeutic group

LIPID MODIFYING AGENTS

Therapeutic indication

Primary hypercholesterolaemia and mixed dyslipidaemia 

Praluent 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.
     

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.

Assessment history

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