This is a summary of the European public assessment report (EPAR) for Betaferon. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Betaferon.
Betaferon : EPAR - Summary for the public (PDF/83.98 KB)
First published: 23/08/2007
Last updated: 05/02/2013
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26/06/2018 Betaferon - EMEA/H/C/000081 - IB/0121
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.