Ravicti

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 glycerol phenylbutyrate

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

Overview

Ravicti is a medicine used to manage urea cycle disorders in adults and children, when the diseases cannot be managed by changes in diet alone. Patients with urea cycle disorders are not able to get rid of waste nitrogen from the body because they lack some liver enzymes. In the body, waste nitrogen is turned into ammonia, which is harmful when it accumulates. Ravicti is used in patients who lack one or more of the following enzymes: carbamoyl phosphate synthase-I, ornithine carbamoyltransferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I and ornithine translocase.

Ravicti contains the active substance glycerol phenylbutyrate.

Urea cycle disorders are rare, and Ravicti was designated an ‘orphan medicine’ (a medicine used in rare diseases) for several forms of the disease on 10 June 2010. Further information on the orphan designations can be found on the European Medicines Agency’s website.

This EPAR was last updated on 29/01/2019

Authorisation details

Product details
Name
Ravicti
Agency product number
EMEA/H/C/003822
Active substance
 glycerol phenylbutyrate
International non-proprietary name (INN) or common name
 glycerol phenylbutyrate
Therapeutic area (MeSH)
Urea Cycle Disorders, Inborn
Anatomical therapeutic chemical (ATC) code
A16AX09
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.

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
Horizon Pharma Ireland Limited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
26/11/2015
Contact address

Connaught House, 1st Floor
1 Burlington Road
Dublin 4, D04C5Y6
Ireland

Product information

18/12/2018 Ravicti - EMEA/H/C/003822 - II/0019

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Assessment history

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