PHEBURANE

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

Active ingredients

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

1 Sodium phenylbutyrate
UNII NT6K61736T - SODIUM PHENYLBUTYRATE

Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate. Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys. On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion.

Read about Sodium phenylbutyrate

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
PHEBURANE Granules 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
A16AX03 Sodium phenylbutyrate 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 A16AX03

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 11865L
Country: CA Health Products and Food Branch Identifier(s): 02436663
Country: EE Ravimiamet Identifier(s): 1621662
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 113822001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 580489
Country: FR Base de données publique des médicaments Identifier(s): 66294104
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 227766
Country: IE Health Products Regulatory Authority Identifier(s): 88264
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7627
Country: IT Agenzia del Farmaco Identifier(s): 042917017, 042917029
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1071078
Country: NL Z-Index G-Standaard, PRK Identifier(s): 108421
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 17661
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100313078

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