Zinbryta : EPAR - Summary for the public (PDF/539.87 KB)
First published: 19/07/2016
Last updated: 02/05/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Biogen Idec Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
70 Norden Road
Berkshire SL6 4AY
27/03/2018 Zinbryta - EMEA/H/C/003862 - IB/0015
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