Ammonaps
sodium phenylbutyrate
Table of contents
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).
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) |
|
Anatomical therapeutic chemical (ATC) code |
A16AX03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Immedica Pharma AB
|
Revision |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
07/12/1999
|
Contact address |
Product information
14/10/2020 Ammonaps - EMEA/H/C/000219 - IB/0059
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.