Kuvan

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sapropterin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 04/03/2020

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
Ringaskiddy Cork Co.
Cork
Ireland

Product information

16/01/2020 Kuvan - EMEA/H/C/000943 - II/0068

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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.

Assessment history

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