KUVAN

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

Active ingredients

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

1 Sapropterin UNII RG277LF5B3 - SAPROPTERIN DIHYDROCHLORIDE

Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan. The rationale for administration of sapropterin in patients with BH4-responsive PKU is to enhance the activity of the defective phenylalanine hydroxylase and thereby increase or restore the oxidative metabolism of phenylalanine. The rationale for administration of sapropterin in patients with BH4 Deficiency is to replace the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase. Read about Sapropterin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KUVAN Soluble 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
A16AX07	Sapropterin	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 A16AX07

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): 10086W, 10087X, 11676M, 11691H, 11970B, 11971C, 11973E, 11983Q, 12569M, 12570N, 12579C
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 542421020000417, 559817080000117
Country: CA	Health Products and Food Branch	Identifier(s): 02350580, 02482207, 02482215
Country: EE	Ravimiamet	Identifier(s): 1391767, 1391789, 1391790, 1750531, 1750542
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 08481002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 166120
Country: FR	Base de données publique des médicaments	Identifier(s): 64768991
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 154184
Country: IE	Health Products Regulatory Authority	Identifier(s): 88945
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6299, 6300
Country: IT	Agenzia del Farmaco	Identifier(s): 038922011, 038922023, 038922035, 038922047, 038922050
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1035323, 1035324, 1035325, 1083948, 1083949
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 89508
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 14913
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100169262, 100419948, 100419954
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W62473001, W62473002, W62473003
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681451379727, 8681451379734, 8681451379741
Country: US	FDA, National Drug Code	Identifier(s): 68135-300, 68135-301, 68135-482