This is a summary of the European public assessment report (EPAR) for Pheburane. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Pheburane.
For practical information about using Pheburane, patients should read the package leaflet or contact their doctor or pharmacist.
Pheburane : EPAR - Summary for the public (PDF/86.79 KB)
First published: 08/08/2013
Last updated: 08/08/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carbamoyl-Phosphate Synthase I Deficiency Disease
|Anatomical therapeutic chemical (ATC) code||
Eurocept International B. V.
|Date of issue of marketing authorisation valid throughout the European Union||
10/12/2021 Pheburane - EMEA/H/C/002500 - IA/0033
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.
Treatment of chronic management of urea-cycle disorders.