Carbaglu

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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 Carbaglu. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Carbaglu.

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Carbaglu
Agency product number
EMEA/H/C/000461
Active substance
carglumic acid
International non-proprietary name (INN) or common name
carglumic acid
Therapeutic area (MeSH)
  • Amino Acid Metabolism, Inborn Errors
  • Propionic Acidemia
Anatomical therapeutic chemical (ATC) code
A16AA05
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Orphan Europe S.A.R.L.
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
23/01/2003
Contact address
Immeuble "Le Wilson"
70, avenue du Général de Gaulle
FR-92800 Puteaux
France

Product information

04/07/2018 Carbaglu - EMEA/H/C/000461 - N/0037

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Carbaglu is indicated in treatment of:

  • hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;
  • hyperammonaemia due to isovaleric acidaemia;
  • hyperammonaemia due to methymalonic acidaemia;
  • hyperammonaemia due to propionic acidaemia.

Assessment history

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