Lojuxta

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lomitapide

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

Overview

This is a summary of the European public assessment report (EPAR) for Lojuxta. 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 Lojuxta.

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

This EPAR was last updated on 04/09/2018

Authorisation details

Product details
Name
Lojuxta
Agency product number
EMEA/H/C/002578
Active substance
Lomitapide
International non-proprietary name (INN) or common name
lomitapide
Therapeutic area (MeSH)
Hypercholesterolemia
Anatomical therapeutic chemical (ATC) code
C10AX12
Additional 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.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Amryt Pharmaceuticals DAC
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
31/07/2013
Contact address
90 Harcourt Street
Dublin 2
Ireland

Product information

27/08/2018 Lojuxta - EMEA/H/C/002578 - T/0031

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

LIPID MODIFYING AGENTS

Therapeutic indication

Lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).

Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.

Assessment history

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