PegIntron

Withdrawn

This medicine's authorisation has been withdrawn

peginterferon alfa-2b

Overview

The marketing authorisation for PegIntron has been withdrawn at the request of the marketing-authorisation holder. 

PegIntron : EPAR - Summary for the public

Product information

PegIntron : EPAR - Product information

Latest procedure affecting product information: T/0135

21/04/2021

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).

PegIntron : EPAR - All Authorised presentations

Product details

• Name of medicine:
  PegIntron
• 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)

PegIntron 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 PegIntron is to be used in combination with these medicines.

Adults (bitherapy and monotherapy)

PegIntron 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.

PegIntron 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 PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.

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

Paediatric population (bitherapy)

PegIntron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have CHC, 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 PegIntron is to be used in combination with ribavirin.

Authorisation details

• EMA product number:
  EMEA/H/C/000280
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Marketing authorisation issued:
  24/05/2000
• Revision:
  36

Assessment history

Changes since initial authorisation of medicine

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

PegIntron-H-C-280-PSUV-0117: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/322518/2014

PegIntron-H-C-280-WS-0216 : EPAR - Assessment Report - Variation

Adopted

CHMP post authorisation summary of positive opinion for Pegintron

AdoptedReference Number: EMA/CHMP/114051/2012

PegIntron-H-C-280-II-0085 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/26391/2010

PegIntron-H-C-208-II-0087 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/43959/2010

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

AdoptedReference Number: EMEA/CHMP/609368/2009

PegIntron-H-C-280-II-0054 : EPAR - Scientific Discussion - Variation

Adopted

PegIntron-H-C-280-II-0069 : EPAR - Scientific Discussion - Variation

Adopted

PegIntron-H-C-280-II-0068 : EPAR - Scientific Discussion - Variation

Adopted

PegIntron-H-C-280-II-0045 : EPAR - Scientific Discussion - Variation

Adopted

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

Initial marketing authorisation documents

PegIntron : EPAR - Scientific Discussion

PegIntron : EPAR - Procedural steps taken before authorisation