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)
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
30/05/2022 Tysabri - EMEA/H/C/000603 - PSUSA/00002127/202108
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.
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