diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Hexacima. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Hexacima.

For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/02/2018

Authorisation details

Product details
Agency product number
Active substance
  • diphtheria toxoid / tetanus toxoid
  • two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin ) / inactivated poliomyelitis virus types 1,2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein
  • hepatitis-B surface antigen
International non-proprietary name (INN) or common name
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)
Therapeutic area (MeSH)
  • Hepatitis B
  • Tetanus
  • Immunization
  • Meningitis, Haemophilus
  • Whooping Cough
  • Poliomyelitis
  • Diphtheria
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Sanofi Pasteur
Date of issue of marketing authorisation valid throughout the European Union
Contact address
14 Espace Henry Vallée

Product information

08/01/2018 Hexacima - EMEA/H/C/002702 - R/0068


  • 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

  • bacterial and viral vaccines combined

Therapeutic indication

Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).

The use of this vaccine should be in accordance with official recommendations.

Assessment history

Changes since initial authorisation of medicine

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