Hexavac

RSS

diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Hexavac has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 16/08/2012

Authorisation details

Product details
Name
Hexavac
Agency product number
EMEA/H/C/000298
Active substance
  • purified diphtheria toxoid
  • Purified Tetanus Toxoid
  • purified pertussis toxoid
  • purified pertussis filamentous haemagglutinin
  • hepatitis B surface antigen
  • Inactivated Type 1 Poliovirus (Mahoney)
  • inactivated type 2 poliovirus (MEF 1)
  • Inactivated Type 3 Poliovirus (Saukett)
  • Haemophilus influenzae type b polysaccharide
International non-proprietary name (INN) or common name
diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
Therapeutic area (MeSH)
  • Hepatitis B
  • Tetanus
  • Immunization
  • Meningitis, Haemophilus
  • Whooping Cough
  • Poliomyelitis
  • Diphtheria
Anatomical therapeutic chemical (ATC) code
J07CA
Publication details
Marketing-authorisation holder
Sanofi Pasteur MSD, SNC
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
23/10/2000
Contact address
Sanofi Pasteur MSD SNC
8 rue Jonas Salk
F-69007 Lyon
FRANCE

Product information

28/06/2012 Hexavac - EMEA/H/C/000298 -

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 combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Assessment history

Changes since initial authorisation of medicine

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