The marketing authorisation for Viraferon has been withdrawn at the request of the marketing authorisation holder.
Viraferon : EPAR - Summary for the public (PDF/263.3 KB)
First published: 27/05/2008
Last updated: 27/05/2008
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Rue de Stalle, 73
22/04/2008 Viraferon - EMEA/H/C/000282 - II/0059
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Product information documents contain:
- summary of product characteristics (annex I);
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- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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:
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).