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)

Opinion on medicine for use outside the European Union
Withdrawn opinion

Overview

The opinion for Hexaxim for use outside the European Union has been withdrawn at the request of the opinion holder.

Opinion details

Product details
Name of medicinal product
Hexaxim
Agency 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Withdrawn opinion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

Product information

24/09/2020 Hexaxim H-W-2495-WS-1792-G

Contents

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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.

Assessment history

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