UCEDANE

This brand name is authorized in Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom

Active ingredients

The drug UCEDANE contains one active pharmaceutical ingredient (API):

1 Carglumic acid UNII 5L0HB4V1EW - CARGLUMIC ACID

Carglumic acid is a carbamoyl phosphate synthetase 1 (CPS 1) allosteric modulator. CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid acts as a replacement for N-acetylglutamate (NAG) in N-acetylglutamate synthase (NAGS) deficiency patients by activating CPS1 but it does not help to regulate the urea cycle. Carglumic acid indicated as adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme NAGS. Read about Carglumic acid

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
UCEDANE Dispersible tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A16AA05	Carglumic acid	A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AA Amino acids and derivatives
Discover more medicines within A16AA05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1748729, 1777844
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171202001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 044691, 194133
Country: FR	Base de données publique des médicaments	Identifier(s): 69083564
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 347541, 373360
Country: IT	Agenzia del Farmaco	Identifier(s): 045485012
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1083208, 1088299
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 81205
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 21260
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100392149
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8682214521414