Viraferon
Withdrawn
This medicine's authorisation has been withdrawn
interferon alfa-2b
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 9 March 2000, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Viraferon (interferon alfa-2b), indicated for the treatment of chronic hepatitis B and chronic hepatitis C.
On 19 September 2008, the marketing authorisation holder (MAH) responsible for Viraferon, Schering-Plough Europe, notified the European Commission of its decision to voluntarily withdraw the marketing authorisation for Viraferon for commercial reasons. The MAH confirmed that this decision is not related to any safety concerns with Viraferon. Viraferon had not been marketed anywhere in the European Union (EU) since early 2007. IntronA is an identical product containing interferon alfa-2b that is available in all areas of the EU, and in particular where Viraferon was previously available.
On 13 October 2008, the European Commission issued a decision to withdraw the marketing authorisation for Viraferon. Pursuant to this decision, the European public assessment report (EPAR) for Viraferon is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0059
22/04/2008
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- Viraferon
- 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
Pharmacotherapeutic group
ImmunostimulantsTherapeutic 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).
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