Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 10 November 2017

Indication(s)

Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.

Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.

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Category Value
Agency product number EMEA/H/C/000943
Orphan designation Yes
Date First Approved 02-12-2008
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder BioMarin International Limited