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
Lojuxta : EPAR - Risk-management-plan summary (PDF/258.51 KB)
First published: 30/11/2021
Last updated: 22/03/2022
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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
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45 Mespil Road
24/02/2022 Lojuxta - EMEA/H/C/002578 - II/0046
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.
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.