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
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Recordati Rare Diseases
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16/05/2019 Carbaglu - EMEA/H/C/000461 - IG/1085/G
- 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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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.