ViraferonPeg

Withdrawn

This medicine's authorisation has been withdrawn

peginterferon alfa-2b

Overview

On 11 January 2021, the European Commission withdrew the marketing authorisation for ViraferonPeg (peginterferon alfa-2b) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

ViraferonPeg was granted marketing authorisation in the EU on 29 May 2000 for the treatment of hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2005. It was then granted unlimited validity in 2010. 

The European Public Assessment Report (EPAR) for ViraferonPeg is updated to indicate that the marketing authorisation is no longer valid.

ViraferonPeg : EPAR - Summary for the public

Product information

ViraferonPeg : EPAR - Product Information

ViraferonPeg : EPAR - All Authorised presentations

Product details

• Name of medicine:
  ViraferonPeg
• Active substance:
  peginterferon alfa-2b
• International non-proprietary name (INN) or common name:
  peginterferon alfa-2b
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  L03AB10

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Adults (tritherapy)

ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.

Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines.

Adults (bitherapy and monotherapy)

ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV.

ViraferonPeg in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy.

Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.

Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with ribavirin.

Paediatric population (bitherapy)

ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA.

When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis.

Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.

Authorisation details

• EMA product number:
  EMEA/H/C/000329
• Marketing authorisation holder:
  Merck Sharp Dohme Ltd

  Merck Sharp Dohme Ltd; Hertford Road; Hoddesdon; Hertfordshire; EN11 9BU; United Kingdom

• Opinion adopted:
  17/02/2000
• Marketing authorisation issued:
  28/05/2000
• Withdrawal of marketing authorisation:
  11/01/2021
• Revision:
  36

Assessment history

Changes since initial authorisation of medicine

ViraferonPeg : EPAR - Procedural steps taken and scientific information after authorisation

ViraferonPeg-H-C-329-PSUV-0110: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/322798/2014

ViraferonPeg-H-C-329-WS-0216 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/393220/2012

CHMP post-authorisation summary of positive opinion for ViraferonPeg

Adopted Reference Number: EMA/CHMP/114049/2012

ViraferonPeg-H-C-329-II-0084 : EPAR - Assessment Report - Variation

Adopted

ViraferonPeg-H-C-329-II-0086 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/6059/2010

CHMP post authorisation summary of positive opinion for ViraferonPeg on 24 September 2009

Adopted Reference Number: EMEA/CHMP/612232/2009

ViraferonPeg-H-C-329-II-0068 : EPAR - Scientific Discussion - Variation

Adopted

ViraferonPeg-H-C-329-II-0067 : EPAR - Scientific Discussion - Variation

Adopted

ViraferonPeg : EPAR - Steps taken after authorisation when a cutoff date has been used

ViraferonPeg-H-C-329-II-0053 : EPAR - Scientific Discussion - Variation

Adopted

ViraferonPeg-H-C-329-II-0045 : EPAR - Scientific Discussion - Variation

Adopted Reference Number: EMEA/H/C/329/II/45

Initial marketing authorisation documents

ViraferonPeg : EPAR - Procedural steps taken before authorisation

ViraferonPeg : EPAR - Scientific Discussion