Tysabri

natalizumab

Overview
Authorisation details
Product information
Assessment history

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.

: Treatment with Tysabri should be started and supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner. This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to the brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with Tysabri and other MS medicines.
Tysabri is given as a 1-hour infusion (drip) into a vein once every 4 weeks. Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for 1 hour afterwards. If there is no clear benefit for the patient after 6 months, the doctor should re-assess the treatment.
The medicine can only be obtained with a prescription.
For more information about using Tysabri, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called α4β1 integrin on white blood cells involved in inflammation. By attaching to integrin, natalizumab is thought to stop white blood cells from entering the brain and spinal cord tissue, thereby reducing inflammation and the resulting nerve damage. This helps to reduce symptoms of the disease.

: Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).
In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabri-treated patients fell by about 68% after a year, compared with the patients who received placebo. In addition, the risk of disability getting worse was reduced by 42% over 2 years with Tysabri in comparison with placebo.
A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses. While the study showed that Tysabri was effective, it also raised concerns that combination with interferon beta-1a increased the risk of the serious brain infection PML.
Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from about 2 to 0.2 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used). The response was maintained for up to 5 years.

: Tysabri can increase the risk of infections, including the brain infection PML. PML is a very serious condition that may result in severe disability or death. The risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than 2 years. The risk is also higher for patients who used medicines that supress the immune system before starting Tysabri, or if the patient has antibodies against the virus that causes PML. If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
The most common side effects with Tysabri (which may affect more than 1 in 10 people) are urinary tract infection, nasopharyngitis (inflammation of the nose and throat), headache, dizziness, nausea (feeling sick), joint pain and tiredness.
About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine’s effectiveness.
Tysabri must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune system is weakened. It must not be given in combination with other disease-modifying medicines or to patients who have cancer (unless it is a skin cancer called basal cell carcinoma).
For the full list of side effects and restrictions of Tysabri, see the package leaflet.

: Studies have shown that Tysabri is effective in treating relapsing-remitting MS. However, because of its safety risks, it should only be used in patients who have a real need for the medicine either because their disease is not sufficiently controlled with at least one other disease-modifying therapy or is rapidly getting worse.
The European Medicines Agency decided therefore that Tysabri’s benefits are greater than its risks and it can be authorised for use in the EU.

: The company that markets Tysabri has agreed on measures to improve the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri. It will also supply all doctors who prescribe Tysabri with an educational pack that includes information on the safety of Tysabri, including information on which patients may be at a higher or lower risk of PML. Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment. The pack will also include information about other risks of this medicine for patients.
Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine. Patients should read this card carefully and keep it with them. Patients should make sure their partner or carer, as well as other doctors treating them, are aware of its content.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tysabri have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tysabri are continuously monitored. Side effects reported with Tysabri are carefully evaluated and any necessary action taken to protect patients.

: Tysabri received a marketing authorisation valid throughout the EU on 27 June 2006.

List item

Tysabri : EPAR - Medicine overview (PDF/135.59 KB)

First published: 18/06/2009
Last updated: 04/05/2020
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Tysabri : EPAR - Risk-management-plan summary (PDF/497.94 KB)

First published: 14/11/2019
Last updated: 13/09/2022

This EPAR was last updated on 13/09/2022

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

Publication details
Marketing-authorisation holder	Biogen Netherlands B.V.
Revision	40
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

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

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Tysabri : EPAR - Product information (PDF/1.37 MB)

First published: 18/06/2009
Last updated: 08/06/2022
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Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

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.

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Tysabri : EPAR - All authorised presentations (PDF/80.35 KB)

First published: 09/11/2007
Last updated: 06/04/2021
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Tysabri : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/43.8 KB)

First published: 31/05/2007
Last updated: 08/07/2011
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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.

Tysabri

Table of contents

Overview

Tysabri : EPAR - Medicine overview (PDF/135.59 KB)

Tysabri : EPAR - Risk-management-plan summary (PDF/497.94 KB)

Authorisation details

Product information

Tysabri : EPAR - Product information (PDF/1.37 MB)

Tysabri : EPAR - All authorised presentations (PDF/80.35 KB)

Tysabri : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/43.8 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Tysabri : EPAR - Procedural steps taken and scientific information after authorisation (PDF/374.7 KB)

Tysabri-H-C-PSUSA-00002127-202108 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/126.92 KB)

Tysabri-H-C-PSUSA-00002127-202008 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/96.16 KB)

Tysabri-H-C-603-X-0116 : EPAR - Assessment report - Extension (PDF/1.71 MB)

CHMP post-authorisation summary of positive opinion for Tysabri (X-116) (PDF/131.35 KB)

Tysabri-H-C-PSUSA-00002127-201908 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.93 KB)

Tysabri-H-C-603-II-77 : EPAR - Assessment Report - Variation (PDF/2.48 MB)

CHMP post-authorisation summary of positive opinion for Tysabri (PDF/121.79 KB)

Tysabri : EPAR - Scientific Conclusion (PDF/72.27 KB)

Tysabri-H-C-603-A20-1416 : EPAR - Assessment Report - Article 20 (PDF/1.4 MB)

Tysabri-H-C-603-PSUV-0062 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/72.55 KB)

Tysabri-H-C-603-II-0059-G : EPAR - Assessment Report - Variation (PDF/738.39 KB)

CHMP post-authorisation summary of positive opinion for Tysabri (PDF/68.45 KB)

Tysabri-H-C-603-A20-0029: EPAR - Assessment Report - Article 20 (PDF/114.16 KB)

Initial marketing-authorisation documents

Tysabri : EPAR - Scientific Discussion (PDF/243.79 KB)

Tysabri : EPAR - Procedural steps taken before authorisation (PDF/198.25 KB)

News

More information on Tysabri

Questions and answers on the review of Tysabri (natalizumab) (PDF/65.06 KB)

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