Ucedane

RSS

carglumic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ucedane. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ucedane.

For practical information about using Ucedane, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 28/09/2017

Authorisation details

Product details
Name
Ucedane
Agency product number
EMEA/H/C/004019
Active substance
carglumic acid
International non-proprietary name (INN) or common name
carglumic acid
Therapeutic area (MeSH)
  • Hyperammonemia
  • Amino Acid Metabolism, Inborn Errors
Anatomical therapeutic chemical (ATC) code
A16AA05
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Lucane Pharma
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/06/2017
Contact address
172 rue de Charonne
Paris 75011
France

Product information

19/07/2017 Ucedane - EMEA/H/C/004019 - IB/0001

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

Treatment of hyperammonaemia due to N-acetylglutamate synthase primary deficiency

Assessment history

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