Tysabri

RSS

natalizumab

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

Overview

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.

This EPAR was last updated on 08/06/2020

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 monitoringAdditional 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
30
Date of issue of marketing authorisation valid throughout the European Union
27/06/2006
Contact address

Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

23/04/2020 Tysabri - EMEA/H/C/000603 - PSUSA/00002127/201908

Contents

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Pharmacotherapeutic group

Selective immunosuppressants

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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