Viraferon (interferon alfa-2b)
- Region
- 🇪🇺 EU
- Active substance
- interferon alfa-2b
- Company
- Schering-Plough Europe
- Status
- Withdrawn
- Therapeutic area
- Hepatitis C, Chronic; Hepatitis B, Chronic
- EU approval
- Thu 09 Mar 2000
- Application
- EMEA/H/C/000282
- ATC
- L03AB05
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Besremi Authorised · AOP Orphan Pharmaceuticals GmbH
- 🇪🇺 IntronA Withdrawn · Merck Sharp & Dohme B.V.
- 🇪🇺 PegIntron Withdrawn · Merck Sharp & Dohme B.V.
- 🇪🇺 ViraferonPeg Withdrawn · Merck Sharp Dohme Ltd
- 🇪🇺 Cylatron Application withdrawn · SP Europe
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.