peginterferon alfa-2a

This medicine is authorised for use in the European Union.


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 20/11/2023

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
pharmaand GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Taborstrasse 1
1020 Vienna

Product information

11/10/2023 Pegasys - EMEA/H/C/000395 - IAIN/0118/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Chronic hepatitis B

Adult patients

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 alanine aminotransferase (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 CHC 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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