Hexaxim - opinion on medicine for use outside EU

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

Overview

The opinion for Hexaxim for use outside the European Union has been withdrawn at the request of the opinion holder.

Hexaxim : Medicine overview

Reference Number: EMA/410207/2016

Product information

Hexaxim : Product information

Latest procedure affecting product information: H-W-2495-WS-1792-G

24/09/2020

Product information documents contain:

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturer responsible for batch release
• Annex IIB - Recommendations to the opinion holder - conditions of use
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Hexaxim : All presentations

Pharmacotherapeutic group

Bacterial and viral vaccines, combined

Therapeutic indication

Hexaxim is indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.

Opinion details

Product details

• Name of medicine:
  Hexaxim
• EMA opinion number:
  H-W-2495
• Opinion status:
  Withdrawn opinion
• Active substance:
  • Diphtheria toxoid
  • Tetanus toxoid
  • Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin
  • Inactivated poliovirus: type 1 (Mahoney strain)
  • Inactivated poliovirus: type 2 (MEF-1 strain)
  • Inactivated poliovirus: type 3 (Saukett strain)
  • hepatitis B surface antigen
  • Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate)
• 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:
  J07CA09

Publication details

• Opinion holder:
  Sanofi Pasteur

  14 Espace Henry Vallee; 69007 Lyon; France

• Date of opinion:
  21/06/2012

Assessment history

Hexaxim : Procedural steps taken and scientific information after opinion

Hexaxim: Withdrawal of the Article 58 scientific opinion - Public statement

Reference Number: EMA/648121/2020

Hexaxim-H-W-2495-P46-021 : Assessment Report

AdoptedReference Number: EMA/237990/2017

Hexaxim-H-W-2495-P46-004 : Assessment Report

AdoptedReference Number: EMA/389260/2016

Hexaxim-H-W-2495-P46-006 : Assessment Report

AdoptedReference Number: EMA/245070/2016

Hexaxim-H-W-2495-P46-015 : Assessment Report

AdoptedReference Number: EMA/245070/2016

Hexaxim : Public assessment report

AdoptedReference Number: EMA/560492/2012

CHMP summary of positive opinion for Hexaxim

AdoptedReference Number: EMA/CHMP/409930/2012