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.
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.
Therapeutic Area (MeSH)
ATC Code
A16AA05
ATC Item
N/A
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| carglumic acid | N/A | carglumic acid |
EMA Name
Carbaglu
Medicine Name
Carbaglu
Aliases
N/ANo risk management plan link.