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 07/08/2019

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoringAdditional 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.

OrphanOrphan

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
3
Date of issue of marketing authorisation valid throughout the European Union
28/08/2015
Contact address

103-105 rue Anatole France
92300 Levallois-Perret
France

Product information

26/07/2019 Kanuma - EMEA/H/C/004004 - IAIN/0021

Contents

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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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