Kanuma

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sebelipase alfa

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

Overview

This is a summary of the European public assessment report (EPAR) for Kanuma. 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 Kanuma.

For practical information about using Kanuma, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 23/11/2017

Authorisation details

Product details
Name
Kanuma
Agency product number
EMEA/H/C/004004
Active substance
sebelipase alfa
International non-proprietary name (INN) or common name
sebelipase alfa
Therapeutic area (MeSH)
Lipid Metabolism, Inborn Errors
Anatomical therapeutic chemical (ATC) code
A16
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Alexion Europe SAS
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
28/08/2015
Contact address
1-15 avenue Edouard Belin
92500 Rueil Malmaison
France

Product information

12/10/2017 Kanuma - EMEA/H/C/004004 - IAIN/0012

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

Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.

Assessment history

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