RAVICTI

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

Active ingredients

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

1 Glycerol phenylbutyrate UNII ZH6F1VCV7B - GLYCEROL PHENYLBUTYRATE

Glycerol phenylbutyrate is a nitrogen-binding medicinal product. Urea cycle disorders (UCDs) are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+). Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients. Glycerol phenylbutyrate is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs). Read about Glycerol phenylbutyrate

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
RAVICTI Oral liquid	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
A16AX09		A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX09

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02453304
Country: EE	Ravimiamet	Identifier(s): 1706093
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151062001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 452031
Country: FR	Base de données publique des médicaments	Identifier(s): 60150015
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 346104
Country: IE	Health Products Regulatory Authority	Identifier(s): 88894
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8691
Country: IT	Agenzia del Farmaco	Identifier(s): 044568018, 044568020, 044568032, 044568044
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1079123
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 150126
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100362119
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66621001, W66621002, W66621003, W66621004
Country: US	FDA, National Drug Code	Identifier(s): 75987-050