Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with the following metabolic diseases: * N acetylglutamate synthase (NAGS) deficiency. Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia. If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood; * some organic acidaemias (isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia) where patients lack certain enzymes involved in protein metabolism. Ucedane contains the active substance carglumic acid and is a ‘generic medicine’. This means that Ucedane contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Carbaglu.
Therapeutic Indication
Ucedane 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
Ucedane
Medicine Name
Ucedane
Aliases
N/ANo risk management plan link.