Betaferon

RSS

interferon beta-1b

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

Overview

Betaferon is a medicine used to treat adults who have multiple sclerosis (MS). MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. Betaferon is used in patients:

  • who have experienced the signs of MS for the first time, and these are severe enough to need treatment with injected corticosteroids (anti-inflammatory medicines). Betaferon is used when the patient is considered to be at high risk of developing MS. Before using Betaferon, doctors need to exclude other causes for the symptoms;
  • who have MS of the type known as ‘relapsing-remitting’, when the patient has attacks (relapses) between periods with no symptoms (remissions), in patients with at least two relapses within the last two years;
  • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.

Betaferon contains the active substance interferon beta-1b.

This EPAR was last updated on 19/12/2019

Authorisation details

Product details
Name
Betaferon
Agency product number
EMEA/H/C/000081
Active substance
interferon beta-1b
International non-proprietary name (INN) or common name
interferon beta-1b
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L03AB08
Publication details
Marketing-authorisation holder
Bayer AG 
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
30/11/1995
Contact address

Bayer AG
51368 Leverkusen
Germany

Product information

19/09/2019 Betaferon - EMEA/H/C/000081 - II/0124/G

Contents

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Pharmacotherapeutic group

Immunostimulants

Therapeutic 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.

Assessment history

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