Pegasys

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peginterferon alfa-2a

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

Overview

This is a summary of the European public assessment report (EPAR) for Pegasys. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pegasys.

For practical information about using Pegasys, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 26/03/2018

Authorisation details

Product details
Name
Pegasys
Agency product number
EMEA/H/C/000395
Active substance
peginterferon alfa-2a
International non-proprietary name (INN) or common name
peginterferon alfa-2a
Therapeutic area (MeSH)
  • Hepatitis C, Chronic
  • Hepatitis B, Chronic
Anatomical therapeutic chemical (ATC) code
L03AB11
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
20/06/2002
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

15/03/2018 Pegasys - EMEA/H/C/000395 - T/0100

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

Chronic hepatitis B

Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).

Paediatric patients 3 years of age and older
Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.

Chronic hepatitis C

Adult patients
Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1).

For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.

Paediatric patients 5 years of age and older
Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.

When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).

Assessment history

Changes since initial authorisation of medicine

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