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Livmarli is a medicine used for treating patients aged 2 months and older with cholestatic pruritis (intense itching due to a build-up of bile) caused by Alagille syndrome.
Alagille syndrome is an inherited disease in which bile (a fluid produced in the liver that helps to break down fats) cannot drain properly from the liver, resulting in a build-up of bile acid in the liver and blood. One of the symptoms of this build-up is cholestatic pruritis.
Alagille syndrome is rare, and Livmarli was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 December 2013. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1214.
Livmarli contains the active substance maralixibat chloride.
Livmarli : EPAR - Medicine Overview (PDF/116.52 KB)
First published: 14/12/2022
Livmarli : EPAR - Risk Management Plan (PDF/481 KB)
First published: 14/12/2022
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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.
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.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Mirum Pharmaceuticals International B.V.
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12/05/2023 Livmarli - EMEA/H/C/005857 - II/0001/G
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.
Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.