Zutectra

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human hepatitis-B immunoglobulin

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 12/06/2018

Authorisation details

Product details
Name
Zutectra
Agency product number
EMEA/H/C/001089
Active substance
human hepatitis-B immunoglobulin
International non-proprietary name (INN) or common name
human hepatitis-B immunoglobulin
Therapeutic area (MeSH)
  • Immunization, Passive
  • Hepatitis B
  • Liver Transplantation
Anatomical therapeutic chemical (ATC) code
J06BB04
Publication details
Marketing-authorisation holder
Biotest Pharma GmbH
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
30/11/2009
Contact address
Landsteinerstrasse 5
D-63303 Dreieich
Germany

Product information

17/05/2018 Zutectra - EMEA/H/C/001089 - WS/1360

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

Immune sera and immunoglobulins

Therapeutic indication

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start.

The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.

Assessment history

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