Ammonaps

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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 22/08/2017

Authorisation details

Product details
Name
Ammonaps
Agency product number
EMEA/H/C/000219
Active substance
Sodium phenylbutyrate
International non-proprietary name (INN) or common name
sodium phenylbutyrate
Therapeutic area (MeSH)
  • Ornithine Carbamoyltransferase Deficiency Disease
  • Citrullinemia
  • Carbamoyl-Phosphate Synthase I Deficiency Disease
Anatomical therapeutic chemical (ATC) code
A16AX03
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum International AB
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
07/12/1999
Contact address
SE-112 76 Stockholm
Sweden

Product information

28/06/2017 Ammonaps - EMEA/H/C/000219 - II/0051

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

Other alimentary tract and metabolism products

Therapeutic indication

Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or
argininosuccinate synthetase.

It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease
(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.

Assessment history

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