Rebif (interferon beta-1a)
- Region
- 🇪🇺 EU
- Active substance
- interferon beta-1a
- Company
- Merck Europe B.V.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- EU approval
- Sun 03 May 1998
- Application
- EMEA/H/C/000136
- ATC
- L03AB07
- Official record
- www.ema.europa.eu
Indication
Rebif is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years. Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Plegridy Authorised · Biogen Netherlands B.V.
- 🇪🇺 Avonex Authorised · Biogen Netherlands B.V.
- 🇪🇺 Biferonex Application withdrawn · BioPartners GmbH
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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.