Viraferon

RSS

interferon alfa-2b

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Viraferon has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 19/11/2008

Authorisation details

Product details
Name
Viraferon
Agency product number
EMEA/H/C/000282
Active substance
interferon alfa-2b
International non-proprietary name (INN) or common name
interferon alfa-2b
Therapeutic area (MeSH)
  • Hepatitis C, Chronic
  • Hepatitis B, Chronic
Anatomical therapeutic chemical (ATC) code
L03AB05
Publication details
Marketing-authorisation holder
Schering-Plough Europe
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
09/03/2000
Contact address
SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Belgium

Product information

22/04/2008 Viraferon - EMEA/H/C/000282 - II/0059

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Chronic Hepatitis B:
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.

Chronic Hepatitis C:
Adult patients:
IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).

The best way to use IntronA in this indication is in combination with ribavirin.

Chidren and adolescents:
IntronA is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

Assessment history

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