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.
Rebif : EPAR - Medicine overview (PDF/125.17 KB)
First published: 26/02/2009
Last updated: 20/12/2019
Rebif : EPAR - Risk-management-plan summary (PDF/239.52 KB)
First published: 16/10/2019
Last updated: 25/02/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
13/02/2020 Rebif - EMEA/H/C/000136 - II/0144
- 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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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.