Avonex
interferon beta-1a
Table of contents
Overview
Avonex is a medicine used to treat:
- patients with relapsing multiple sclerosis (MS). MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. In relapsing MS, the patient has attacks (relapses) between periods with no symptoms. Avonex slows the progression of disability and reduces the number of relapses;
- patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti‑inflammatory medicines). It is used when the patient is considered to be at high risk of developing MS. Before using Avonex, doctors need to exclude other causes for the symptoms.
Avonex contains the active substance interferon beta-1a.
This EPAR was last updated on 12/03/2021
Authorisation details
Product details | |
---|---|
Name |
Avonex
|
Agency product number |
EMEA/H/C/000102
|
Active substance |
interferon beta-1a
|
International non-proprietary name (INN) or common name |
interferon beta-1a
|
Therapeutic area (MeSH) |
Multiple Sclerosis
|
Anatomical therapeutic chemical (ATC) code |
L03AB07
|
Publication details | |
---|---|
Marketing-authorisation holder |
Biogen Netherlands B.V.
|
Revision |
34
|
Date of issue of marketing authorisation valid throughout the European Union |
13/03/1997
|
Contact address |
Biogen Netherlands B.V. |
Product information
11/02/2021 Avonex - EMEA/H/C/000102 - IAIN/0187/G
Contents
- 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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Pharmacotherapeutic group
Pharmacotherapeutic group
Immunostimulants
Therapeutic indication
Therapeutic indication
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.