Carbaglu
carglumic acid
Table of contents
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.
Authorisation details
Product details | |
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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) |
|
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 | |
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Marketing-authorisation holder |
Orphan Europe S.A.R.L.
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
24/01/2003
|
Contact address |
Product information
04/07/2018 Carbaglu - EMEA/H/C/000461 - N/0037
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
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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.