Infergen

Withdrawn

This medicine's authorisation has been withdrawn

interferon alfacon-1

Overview

On 1 February 1999 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Infergen, solution for injection, intended for the treatment of patients of 18 years and older with chronic hepatitis C virus and serum markers for hepatitis C virus (HCV) infection. 

Infergen is currently marketed in Czech Republic, France, Germany and Italy. The Marketing Authorisation Holder responsible for this medicinal product is Astellas Pharma Europe B.V. On 6 April 2006, the European Commission was notified by Astellas Pharma Europe B.V. of its decision to voluntarily withdraw the marketing authorisation for Infergen for commercial reasons. Therapeutic alternatives are available throughout the European Union, including alpha interferons, pegylated alpha interferons and ribavirin for use with (pegylated) alpha interferons in combination therapy. 

On 5 May 2006 the European Commission issued, a decision to withdraw the marketing authorisation for Infergen. Pursuant to this decision the European Public Assessment Report for Infergen has been removed from this website. The Marketing Authorisation Holder for Infergen continues to be responsible for any remaining product on the market until the expiry date (November 2007) of the latest released batch in the European Union.

Product information

Product details

• Name of medicine:
  Infergen
• Active substance:
  interferon alfacon-1
• International non-proprietary name (INN) or common name:
  interferon alfacon-1
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  L03AB09

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Treatment of patients of 18 years and older with chronic hepatitis and serum markers for hepatitis C virus (HCV) infection e.g. those who have elevated serum transaminase levels without decompensated liver disease and who are positive for serum HCV-RNA (see section 4.4). Consideration should be given to current official guidance on the appropriate use of interferons for the treatment of patients with chronic hepatitis C.
Interferon alfacon-1 should be given alone mainly in case of intolerance or contraindication to ribavirin.

Authorisation details

• EMA product number:
  EMEA/H/C/000186
• Marketing authorisation holder:
  Astellas Pharma Europe B.V.

  Elisabethhof 19; NL-2350 AC Leiderdorp; The Netherlands

• Marketing authorisation issued:
  01/02/1999
• Withdrawal of marketing authorisation:
  05/05/2006
• Revision:
  8