This is a summary of the European public assessment report (EPAR) for Avonex. 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 Avonex.
Avonex : EPAR - Summary for the public (PDF/73.77 KB)
First published: 19/03/2009
Last updated: 22/09/2011
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Blogen Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
02/08/2018 Avonex - EMEA/H/C/000102 - T/0178
- 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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Avonex is indicated for the treatment of:
- patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses;
- 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 MS.
Avonex should be discontinued in patients who develop progressive MS.