Basic Information
Ucedane
Regulatory Information
EMEA/H/C/004019
June 23, 2017
April 21, 2017
13
September 24, 2024
Company Information
the netherlands
Trapgans 5 1244 RL Ankeveen
Eurocept International B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.