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 23/06/2023

Authorisation details

Product details
Agency product number
Active substance
  • hepatitis B surface antigen
  • Diphtheria toxoid
  • tetanus toxoid
  • Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin
  • poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett)
  • Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein
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
69007 Lyon

Product information

22/06/2023 Hexacima - EMEA/H/C/002702 - WS2468/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Vaccines

  • 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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