Infanrix Hexa


diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) 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 Infanrix hexa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Infanrix hexa.

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

This EPAR was last updated on 21/09/2023

Authorisation details

Product details
Infanrix Hexa
Agency product number
Active substance
  • Diphtheria toxoid
  • tetanus toxoid
  • Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin)
  • hepatitis B surface antigen
  • poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain))
  • Haemophilus influenzae type b polysaccharide
International non-proprietary name (INN) or common name
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) 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
GlaxoSmithKline Biologicals S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Rue de l'Institut, 89
B-1330 Rixensart

Product information

26/04/2023 Infanrix Hexa - EMEA/H/C/000296 - WS2365

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


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


Therapeutic indication

Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
2 ratings
1 rating
7 ratings