This is a summary of the European public assessment report (EPAR) for Tysabri. 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 Tysabri.
For practical information about using Tysabri, patients should read the package leaflet or contact their doctor or pharmacist.
Tysabri : EPAR - Summary for the public (PDF/92.42 KB)
First published: 18/06/2009
Last updated: 31/05/2017
Tysabri : EPAR - Risk-management-plan summary (PDF/149.71 KB)
First published: 14/11/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Biogen Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
03/10/2019 Tysabri - EMEA/H/C/000603 - II/0114
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups:
- Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1)
- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21 January 201028/01/2010
European Medicines Agency recommends additional measures to better manage risk of progressive multifocal leukoencephalopathy (PML) with Tysabri21/01/2010
European Medicines Agency recommends update of product information of Tysabri and risk of progressive multifocal leukoencephalopathy (PML)25/09/2008
European Medicines Agency concludes new advice to doctors and patients for Tysabri (natalizumab) needed20/03/2008