Hepacare

triple antigen hepatitis B vaccine (recombinant)

The marketing authorisation for Hepacare has been withdrawn at the request of the marketing authorisation holder.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

More detail is available in the summary of product characteristics

Product details

Publication details

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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents