sodium phenylbutyrate

This medicine is authorised for use in the European Union.


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 13/12/2021

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Eurocept International B. V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Trapgans 5
1244 RL Ankeveen
The Netherlands

Product information

10/12/2021 Pheburane - EMEA/H/C/002500 - IA/0033

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Product information documents contain:

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.

Pharmacotherapeutic group

Various alimentary tract and metabolism products

Therapeutic indication

Treatment of chronic management of urea-cycle disorders.

Assessment history

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