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.
Carbaglu : EPAR - Summary for the public (PDF/71.27 KB)
First published: 08/04/2009
Last updated: 19/07/2011
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Orphan Europe S.A.R.L.
|Date of issue of marketing authorisation valid throughout the European Union||
04/07/2018 Carbaglu - EMEA/H/C/000461 - N/0037
- 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.
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Other alimentary tract and metabolism products
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.