Extavia

RSS

interferon beta-1b

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

Overview

This is a summary of the European public assessment report (EPAR) for Extavia. 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 Extavia.

This EPAR was last updated on 26/07/2018

Authorisation details

Product details
Name
Extavia
Agency product number
EMEA/H/C/000933
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
Novartis Europharm Ltd
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
20/05/2008
Contact address
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

14/06/2018 Extavia - EMEA/H/C/000933 - IA/0092

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

Extavia 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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