RAVICTI

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

Active ingredients

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

1
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 more about Glycerol phenylbutyrate

Medication package inserts

Below package inserts are available for further reading:

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

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