Public Statement on Viraferon (Interferon Alfa-2b) Withdrawal of the Marketing Authorisation in the European Union

Public Statement on Viraferon (Interferon Alfa-2b) Withdrawal of the Marketing Authorisation in the European Union

LONDON, Nov. 20, 2008-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European public assessment report (EPAR) for Viraferon will be updated to reflect that the marketing authorisation is no longer valid.

Noël Wathion Head of Unit for the Post-Authorisation Evaluation of Medicinal Products for Human use
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
E-mail: mail@emea.europa.eu http://www.emea.europa.eu