TYSABRI
As listed in the register: TYSABRI 150 mg, solution injectable en seringue préremplie
150 mg · solution injectable
- Prescription only
- Active substance
- Natalizumab
- Made by
- BIOGEN NETHERLANDS (PAYS-BAS)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (TYSABRI). It describes the substance, not this exact product.
Natalizumab binds to the α4-subunit of α4β1 and α4β7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s).
The receptors for the α4 family of integrins include vascular cell adhesion molecule-1 (VCAM-1), which is expressed on activated vascular endothelium, and mucosal addressin cell adhesion molecule-1 (MAdCAM-1) present on vascular endothelial cells of the gastrointestinal tract.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-03-21
Safety of the active substance
From the US prescribing label for the same active substance (TYSABRI). It describes the substance, not this exact product.
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
- TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [ see Warnings and Precautions ( 5.1 ) ].
- Observed reactions range from urticaria to anaphylaxis [ see Warnings and Precautions ( 5.5 ) ].
- Patients who have or have had PML ( 4 ) Patients who have had a hypersensitivity reaction to TYSABRI ( 4, 5.3 )
The most common adverse reactions (incidence ≥ 10%) were headache and fatigue in both the multiple sclerosis (MS) and Crohn's disease (CD) studies.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
Spain1 matching products
CanadaNo exact match for this strength and form
Details
| Made by | BIOGEN NETHERLANDS (PAYS-BAS) |
|---|---|
| Active substance | Natalizumab |
| Strength | 150 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription initiale hospitalière semestrielle · prescription initiale réservée à certains spécialistes · renouvellement de la prescription réservé aux spécialistes en NEUROLOGIE · liste I · les six premières administrations doivent être effectuées en milieu hospitalier |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/06/346 |
| Name in the register | TYSABRI 150 mg, solution injectable en seringue préremplie |
| Packs | 2 seringue(s) préremplie(s) en verre de 1 ml · 2 seringue(s) préremplie(s) en verre de 1 ml ( abrogée le 14/05/2025) |
| CIS | 61863110 |
| CIP13 | 3400930318553 |
| CIP13 | 3400955080381 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution injectable1 products
- 150 mg
- solution à diluer pour perfusion1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.