Tysabri

RSS

natalizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/08/2018

Authorisation details

Product details
Name
Tysabri
Agency product number
EMEA/H/C/000603
Active substance
natalizumab
International non-proprietary name (INN) or common name
natalizumab
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AA23
Additional monitoring

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.

Publication details
Marketing-authorisation holder
Biogen Netherlands B.V.
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
26/06/2006
Contact address

Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

01/08/2018 Tysabri - EMEA/H/C/000603 - T/0110

Contents

  • 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.

Pharmacotherapeutic group

Selective immunosuppressive agent

Therapeutic indication

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)

    or
  • 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.

Assessment history

Changes since initial authorisation of medicine

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