Ravicti

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 glycerol phenylbutyrate

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

Overview

This is a summary of the European public assessment report (EPAR) for Ravicti. 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 Ravicti.

For practical information about using Ravicti, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/11/2018

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 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.

Orphan

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
9
Date of issue of marketing authorisation valid throughout the European Union
26/11/2015
Contact address
Connaught House
1 Burlington Road
Dublin
D04C5Y6
Ireland

Product information

18/10/2018 Ravicti - EMEA/H/C/003822 - II/0023

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age 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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