Livmarli

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Maralixibat chloride

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

Overview

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.

This EPAR was last updated on 14/12/2022

Authorisation details

Product details
Name
Livmarli
Agency product number
EMEA/H/C/005857
Active substance
Maralixibat chloride
International non-proprietary name (INN) or common name
Maralixibat chloride
Therapeutic area (MeSH)
Alagille Syndrome
Anatomical therapeutic chemical (ATC) code
A05AX04
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.

Exceptional circumstancesExceptional 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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Mirum Pharmaceuticals International B.V.
Date of issue of marketing authorisation valid throughout the European Union
09/12/2022
Contact address

Kingsfordweg 151
1043 GR Amsterdam
Netherlands

Product information

Livmarli - EMEA/H/C/005857 -

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Product information documents contain:

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.

Pharmacotherapeutic group

Other drugs for bile therapy

Therapeutic indication

Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.

Assessment history

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