Praluent

RSS

alirocumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Praluent. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Praluent.

For practical information about using Praluent, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/10/2018

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
10
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

18/09/2018 Praluent - EMEA/H/C/003882 - IAIN/0043

Contents

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Pharmacotherapeutic group

LIPID MODIFYING AGENTS

Therapeutic indication

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.

The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.

Assessment history

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