Tysabri (natalizumab)
- Region
- 🇪🇺 EU
- Active substance
- natalizumab
- Company
- Biogen Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- EU approval
- Tue 27 Jun 2006
- Application
- EMEA/H/C/000603
- ATC
- L04AG03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tyruko Authorised · Sandoz GmbH
- 🇪🇺 Natalizumab Elan Pharma Refused · Elan Pharma International Ltd.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.