Table of contents
The marketing authorisation for Zinbryta has been withdrawn at the request of the marketing authorisation holder.
Zinbryta : EPAR - Summary for the public (PDF/539.87 KB)
First published: 19/07/2016
Last updated: 02/05/2018
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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.
Biogen Idec Ltd
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70 Norden Road
Berkshire SL6 4AY
27/03/2018 Zinbryta - EMEA/H/C/003862 - IB/0015
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders02/03/2018
PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage27/10/2017