CARBAGLU

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

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 more about Carglumic acid

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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