Brineura

RSS

cerliponase 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 Brineura. 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 Brineura.

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

This EPAR was last updated on 16/08/2022

Authorisation details

Product details
Name
Brineura
Agency product number
EMEA/H/C/004065
Active substance
cerliponase alfa
International non-proprietary name (INN) or common name
cerliponase alfa
Therapeutic area (MeSH)
Neuronal Ceroid-Lipofuscinoses
Anatomical therapeutic chemical (ATC) code
A16AB
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.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

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
BioMarin International Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
30/05/2017
Contact address

Shanbally
Ringaskiddy Cork Co.
Cork
Ireland

Product information

28/03/2022 Brineura - EMEA/H/C/004065 - R/0034

Other EU languages available icon 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:

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

Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency

Assessment history

Related content

How useful was this page?

Add your rating