Viraferon
interferon alfa-2b
Table of contents
Overview
The marketing authorisation for Viraferon has been withdrawn at the request of the marketing authorisation holder.
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) |
|
| 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
This medicine’s product information is available in all official EU languages.
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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).