Basic Information
Brineura
Regulatory Information
EMEA/H/C/004065
Authorised
May 30, 2017
April 21, 2017
7
December 12, 2023
Company Information
Ireland
Shanbally Ringaskiddy Cork Co. Cork
Biomarin International Limited
Drug Classification
Orphan MedicineAdditional MonitoringExceptional CircumstancesAccelerated Assessment
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency
Overview Summary
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.