triple antigen hepatitis B vaccine (recombinant)

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The marketing authorisation for Hepacare has been withdrawn at the request of the marketing authorisation holder.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

Product details for Hepacare
Agency product numberEMEA/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 Hepatitis BImmunization
Anatomical therapeutic chemical (ATC) code J07BC

Publication details

Publication details for Hepacare
Marketing-authorisation holder

Evans Vaccines Ltd.

Date of issue of marketing authorisation valid throughout the European Union04/08/2000

Contact address:

Evans Vaccines Limited
Gaskill Road
L24 9GR
United Kingdom

Product information

Product information

23/10/2002  Hepacare -EMEA/H/C/000261


  • 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


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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated


This medicine is now withdrawn from use in the European Union

More information on Hepacare