Rebif

RSS

interferon beta-1a

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

Overview

Rebif 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. Relapsing MS is the type of MS where the patient has attacks (relapses) between periods with no symptoms. Rebif’s effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS) that is not relapsing.

Rebif can also be used in patients who have had a single attack of demyelination accompanied by inflammation. It is used when the patient is considered to be at high risk of developing MS. Before using Rebif, doctors need to exclude other causes for the symptoms.

Rebif contains the active substance interferon beta-1a.

This EPAR was last updated on 30/01/2020

Authorisation details

Product details
Name
Rebif
Agency product number
EMEA/H/C/000136
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
Merck Europe B.V. 
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
03/05/1998
Contact address

Gustav Mahlerplein 102
Ito Toren
1082 MA Amsterdam
The Netherlands

Product information

08/01/2020 Rebif - EMEA/H/C/000136 - IB/0143

Contents

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Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Rebif is indicated for the treatment of:

  • patients with a single demyelinating event with an active inflammatory process, 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 multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years.

Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.

Assessment history

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