Ravicti
glycerol phenylbutyrate
Table of contents
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.
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Ravicti : EPAR - Summary for the public (PDF/78.75 KB)
First published: 18/12/2015
Last updated: 29/01/2019 -
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Ravicti : EPAR - Risk-management-plan summary (PDF/734.59 KB)
First published: 18/12/2015
Last updated: 03/10/2019
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Immedica Pharma AB
|
Revision |
12
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Date of issue of marketing authorisation valid throughout the European Union |
26/11/2015
|
Contact address |
Product information
25/08/2020 Ravicti - EMEA/H/C/003822 - R/0034
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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).