Kuvan
sapropterin
Table of contents
Overview
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.
-
List item
Kuvan : EPAR - Summary for the public (PDF/78.78 KB)
First published: 16/01/2009
Last updated: 09/11/2017 -
-
List item
Kuvan : EPAR - Risk-management-plan summary (PDF/130.67 KB)
First published: 10/01/2020
Authorisation details
Product details | |
---|---|
Name |
Kuvan
|
Agency product number |
EMEA/H/C/000943
|
Active substance |
Sapropterin dihydrochloride
|
International non-proprietary name (INN) or common name |
sapropterin
|
Therapeutic area (MeSH) |
Phenylketonurias
|
Anatomical therapeutic chemical (ATC) code |
A16AX07
|
Publication details | |
---|---|
Marketing-authorisation holder |
BioMarin International Limited
|
Revision |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
02/12/2008
|
Contact address |
Shanbally |
Product information
16/01/2020 Kuvan - EMEA/H/C/000943 - II/0068
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other alimentary tract and metabolism products
Therapeutic indication
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.