Infergen

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interferon alfacon-1

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Infergen has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 01/06/2006

Authorisation details

Product details
Name
Infergen
Agency product number
EMEA/H/C/000186
Active substance
interferon alfacon-1
International non-proprietary name (INN) or common name
interferon alfacon-1
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
L03AB09
Publication details
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
01/02/1999
Contact address
Elisabethhof 19
NL-2350 AC Leiderdorp
The Netherlands

Product information

05/05/2006 Infergen - EMEA/H/C/000186 -

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

Treatment of patients of 18 years and older with chronic hepatitis and serum markers for hepatitis C virus (HCV) infection e.g. those who have elevated serum transaminase levels without decompensated liver disease and who are positive for serum HCV-RNA (see section 4.4). Consideration should be given to current official guidance on the appropriate use of interferons for the treatment of patients with chronic hepatitis C.
Interferon alfacon-1 should be given alone mainly in case of intolerance or contraindication to ribavirin.

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