Rebif

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 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.

This EPAR was last updated on 06/02/2018

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 Serono Europe Ltd
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
03/05/1998
Contact address
56 Marsh Wall
London E14 9TP
United Kingdom

Product information

18/12/2017 Rebif - EMEA/H/C/000136 - IB/0133/G

Contents

  • 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

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

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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