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 30/05/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
BioMarin International Limited
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
02/12/2008
Contact address
Shanbally
Ringaskiddy Cork Co.
Cork
Ireland

Product information

12/04/2018 Kuvan - EMEA/H/C/000943 - II/0052

Contents

  • 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.

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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