Hexyon

RSS

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Hexyon. 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 Hexyon.

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

This EPAR was last updated on 22/05/2018

Authorisation details

Product details
Name
Hexyon
Agency product number
EMEA/H/C/002796
Active substance
  • Diphtheria toxoid
  • filamentous haemagglutinin
  • hepatitis B surface antigen
  • pertussis toxoid
  • tetanus toxoid
  • Haemophilus influenzae type b polysaccharide
  • polyribosylribitol phosphate conjugated to tetanus protein
  • type 1 (mahoney)
  • type 2 (mef-1)
  • type 3 (saukett)
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
J07CA09
Publication details
Marketing-authorisation holder
Sanofi Pasteur Europe
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
17/04/2013
Contact address
14 Espace Henry Valllée
69007 Lyon
France

Product information

08/12/2017 Hexyon - EMEA/H/C/002796 - IG/0869

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

Hexyon (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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