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||
30/08/2019 Pheburane - EMEA/H/C/002500 - N/0024
- 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
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Treatment of chronic management of urea-cycle disorders.