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.
For practical information about using Kuvan, patients should read the package leaflet or contact their doctor or pharmacist.
Kuvan : EPAR - Summary for the public (PDF/78.78 KB)
First published: 16/01/2009
Last updated: 09/11/2017
Kuvan : EPAR - Risk-management-plan summary (PDF/130.67 KB)
First published: 10/01/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
BioMarin International Limited
|Date of issue of marketing authorisation valid throughout the European Union||
28/10/2019 Kuvan - EMEA/H/C/000943 - IB/0069
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Other alimentary tract and metabolism products
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.