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sapropterin (Kuvan)

Advice

In the absence of a submission from the holder of the marketing authorisation.

sapropterin (Kuvan) is not recommended for use within NHSScotland for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU) and for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with tetrahydrobiopterin (BH4) deficiency.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.

Drug Details

Drug Name: sapropterin (Kuvan)
SMC Drug ID: 558/09
Manufacturer: Merck Serono Ltd
Indication: For the treatment of hyperphenylalaninaemia (HPA)
BNF Category:
Sub Category: 9.4 Oral nutrition
Submission Type: Non submission
Status: Not Recommended
Date Advice Published: 8 June 2009

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