KUVAN

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

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 more about Sapropterin

Medication package inserts

Below package inserts are available for further reading:

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