Praluent
alirocumab
Table of contents
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.
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List item
Praluent : EPAR - Medicine overview (PDF/126.89 KB)
First published: 01/10/2015
Last updated: 01/03/2021
EMA/383130/2020 -
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List item
Praluent : EPAR - Risk-management-plan summary (PDF/80.73 KB)
First published: 01/10/2015
Last updated: 17/02/2022
Authorisation details
Product details | |
---|---|
Name |
Praluent
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Agency product number |
EMEA/H/C/003882
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Active substance |
Alirocumab
|
International non-proprietary name (INN) or common name |
alirocumab
|
Therapeutic area (MeSH) |
Dyslipidemias
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Anatomical therapeutic chemical (ATC) code |
C10AX14
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Publication details | |
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Marketing-authorisation holder |
Sanofi Winthrop Industrie
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Revision |
21
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Date of issue of marketing authorisation valid throughout the European Union |
23/09/2015
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Contact address |
82 Avenue Raspail |
Product information
29/11/2023 Praluent - EMEA/H/C/003882 - IAIN/0087
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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
News
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13/10/2023
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
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29/04/2016
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24/07/2015
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24/07/2015