🇪🇺 Interferon-β-1 in European Union

EMA authorised Interferon-β-1 on 30 November 1995

Marketing authorisations

Application: EMEA/H/C/000081
Marketing authorisation holder: Bayer AG
Local brand name: Betaferon
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.
Status: approved

Application: EMEA/H/C/000933
Marketing authorisation holder: Novartis Europharm Limited
Local brand name: Extavia
Indication: Extavia 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.
Status: withdrawn

Is Interferon-β-1 approved in European Union?

Yes. EMA authorised it on 30 November 1995; EMA authorised it on 20 May 2008.

Who is the marketing authorisation holder for Interferon-β-1 in European Union?

Bayer AG holds the EU marketing authorisation.