Tysabri is a medicine for treating adults with multiple sclerosis (MS) that is not sufficiently controlled with another disease-modifying therapy or is rapidly getting worse.
Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding nerves and damages the nerves themselves.
Tysabri is used in relapsing-remitting MS, a type of MS in which the patient has attacks (relapses) between periods of stable symptoms (remissions).
It contains the active substance natalizumab.
Tysabri : EPAR - Medicine overview (PDF/135.59 KB)
First published: 18/06/2009
Last updated: 04/05/2020
Tysabri : EPAR - Risk-management-plan summary (PDF/288.18 KB) (updated)
First published: 14/11/2019
Last updated: 06/04/2021
|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||
Prins Mauritslaan 13
26/03/2021 Tysabri - EMEA/H/C/000603 - X/0116
- 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
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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) 25-29 January 202129/01/2021
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