PegIntron

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peginterferon alfa-2b

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for PegIntron. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PegIntron.

This EPAR was last updated on 11/12/2018

Authorisation details

Product details
Name
PegIntron
Agency product number
EMEA/H/C/000280
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
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
24/05/2000
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

28/09/2018 PegIntron - EMEA/H/C/000280 - T/0135

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Changes since initial authorisation of medicine

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