<p>This is a summary of the European public assessment report (EPAR) for Kuvan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kuvan.</p><p>For practical information about using Kuvan, patients should read the package leaflet or contact their doctor or pharmacist.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>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.</p> <p>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.</p></div>
Therapeutic Area (MeSH)
ATC Code
A16AX07
ATC Item
N/A
Pharmacotherapeutic Group
Other alimentary tract and metabolism products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sapropterin dihydrochloride | N/A | sapropterin dihydrochloride |
EMA Name
Kuvan
Medicine Name
Kuvan
Aliases
N/ANo risk management plan link.
