CARBAGLU

This brand name is authorized in Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

Active ingredients

The drug CARBAGLU 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
CARBAGLU 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: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 576920060000307, 576920060000407, 576920060000507
Country: CA	Health Products and Food Branch	Identifier(s): 02439360
Country: EE	Ravimiamet	Identifier(s): 1200362, 1200373, 1200384
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 02246002, 02246003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 014867, 014889, 024112
Country: FR	Base de données publique des médicaments	Identifier(s): 65296084
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 95129, 95130, 95131
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6935, 6936
Country: IT	Agenzia del Farmaco	Identifier(s): 035983028
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999041X1026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1028064, 1028065, 1028066
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100133672
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68681001, W68681002, W68681003
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699960580121
Country: US	FDA, National Drug Code	Identifier(s): 52276-312