Avonex

RSS

interferon beta-1a

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 29/11/2018

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
Blogen Netherlands B.V. 
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
13/03/1997
Contact address
Blogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

02/08/2018 Avonex - EMEA/H/C/000102 - T/0178

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunostimulants

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.

Assessment history

How useful was this page?

Add your rating