Natalizumab Elan Pharma (natalizumab)
- Region
- 🇪🇺 EU
- Active substance
- natalizumab
- Company
- Elan Pharma International Ltd.
- Status
- Refused
- Therapeutic area
- Crohn Disease
- CHMP opinion
- Thu 15 Nov 2007
- Application
- EMEA/H/C/000624
- ATC
- L03AD
- Official record
- www.ema.europa.eu
Indication
Treatment of moderately to severely active Crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tyruko Authorised · Sandoz GmbH
- 🇪🇺 Tysabri Authorised · Biogen Netherlands B.V.
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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.