Extavia

Withdrawn

This medicine's authorisation has been withdrawn

interferon beta-1b

Overview

On 25 November 2024, the European Commission withdrew the marketing authorisation for Extavia (interferon beta-1B) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Extavia was granted marketing authorisation in the EU on 20 May 2008 for the treatment of single demyelinating events with an active inflammatory process and multiple sclerosis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2012.

Extavia is identical to Betaferon which is authorised in the EU with the same indication as Extavia.

Extavia : EPAR - Summary for the public

Reference Number: EMA/307167/2012

Extavia : EPAR - Risk-management-plan summary

Product information

Extavia : EPAR - Product Information

Extavia : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Extavia
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000933
• Marketing authorisation holder:
  Novartis Europharm Limited

  Vista Building; Elm Park; Merrion Road; Dublin 4; Ireland

• Opinion adopted:
  19/03/2008
• Marketing authorisation issued:
  20/05/2008
• Withdrawal of marketing authorisation:
  25/04/2025
• Revision:
  26

Assessment history

Changes since initial authorisation of medicine

Extavia : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Extavia : EPAR - Public assessment report

CHMP summary of positive opinion for Extavia

Reference Number: EMEA/CHMP/138637/2008