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.
Lojuxta : EPAR - Summary for the public (PDF/80.52 KB)
First published: 03/09/2013
Last updated: 11/03/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
Amryt Pharmaceuticals DAC
|Date of issue of marketing authorisation valid throughout the European Union||
45 Mespil Road
07/12/2020 Lojuxta - EMEA/H/C/002578 - IAIN/0045
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.
Lipid modifying agents
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.