Hepacare

RSS

triple antigen hepatitis B vaccine (recombinant)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Hepacare has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 17/12/2002

Authorisation details

Product details
Name
Hepacare
Agency product number
EMEA/H/C/000261
Active substance
hepatitis B, recombinant surface antigen
International non-proprietary name (INN) or common name
triple antigen hepatitis B vaccine (recombinant)
Therapeutic area (MeSH)
  • Hepatitis B
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BC
Publication details
Marketing-authorisation holder
Evans Vaccines Ltd.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
04/08/2000
Contact address
Evans Vaccines Limited
Gaskill Road
Speke
Liverpool
L24 9GR
United Kingdom

Product information

23/10/2002 Hepacare - EMEA/H/C/000261 -

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

VACCINES

Therapeutic indication

This vaccine is indicated for active immunisation against hepatitis B virus infection in non-immune adults (>=18 years). The specific at risk categories to be immunised are to be determined on the basis of official recommendations.

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