This is a summary of the European public assessment report (EPAR) for Rebif. 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 Rebif.
Rebif : EPAR - Summary for the public (PDF/85.19 KB)
First published: 26/02/2009
Last updated: 29/04/2014
Rebif : EPAR - Risk-management-plan summary (PDF/193.54 KB)
First published: 16/10/2019
|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||
19/09/2019 Rebif - EMEA/H/C/000136 - II/0137/G
- 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.