Pheburane

RSS

sodium 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 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.

This EPAR was last updated on 29/09/2017

Authorisation details

Product details
Name
Pheburane
Agency product number
EMEA/H/C/002500
Active substance
Sodium phenylbutyrate
International non-proprietary name (INN) or common name
sodium phenylbutyrate
Therapeutic area (MeSH)
Carbamoyl-Phosphate Synthase I Deficiency Disease
Anatomical therapeutic chemical (ATC) code
A16AX03
Publication details
Marketing-authorisation holder
Lucane Pharma
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
31/07/2013
Contact address
172 rue de Charonne
75011 Paris
France

Product information

20/07/2017 Pheburane - EMEA/H/C/002500 - IB/0016

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.

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

Pharmacotherapeutic group

Various alimentary tract and metabolism products

Therapeutic indication

Treatment of chronic management of urea-cycle disorders.

Assessment history

How useful was this page?

Add your rating