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Sapropterin hydrochloride
Trade Name:
Kuvan
Manufacturer/Distributor:
BioMarin Pharmaceuticals (Canada)
www.bmrn.com www.kuvan.com 1-877-597-6744
Classification:
Used in phenylketonuria
ATC Class:
A16AX07 - alimentary tract and metabolism products
Status:
active
Notice of Compliance (yyyy/mm/dd):
2010/04/30
Date Marketed in Canada (yyyy/mm/dd):
2010/07/05
Presentation:
tablet: 100mg. DIN: 02350580
Comments:
FDA approval: December 2007. Distribution in US to be through a limited network of specialty pharmacies.
Approved for use in Europe by EMEA in December 2008.
April 2010 - approved for use in Canada.
Synthetic dihydrochloride salt of naturally occurring tetrahydrobiopterin, which is a cofactor in the metabolism of phenylalanine.
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