Betaferon (interferon beta-1b)
- Region
- 🇪🇺 EU
- Active substance
- interferon beta-1b
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- CHMP opinion
- Wed 12 Jul 1995
- EU approval
- Thu 30 Nov 1995
- Application
- EMEA/H/C/000081
- ATC
- L03AB08
- Official record
- www.ema.europa.eu
Indication
Betaferon is indicated for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, 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-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Extavia Withdrawn · Novartis Europharm Limited
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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.