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
Opinion details
Product information
Assessment history

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Withdrawn opinion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The opinion for Hexaxim for use outside the European Union has been withdrawn at the request of the opinion holder.

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Hexaxim : Medicine overview (PDF/665.99 KB)

First published: 04/12/2012
Last updated: 14/06/2016
EMA/410207/2016

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Opinion status	Withdrawn opinion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

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Hexaxim : Product information (PDF/1.46 MB)

First published: 04/12/2012
Last updated: 19/11/2020

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

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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.

Hexaxim: Opinion on medicine for use outside EU

Table of contents

Overview

Hexaxim : Medicine overview (PDF/665.99 KB)

Opinion details

Product information

Hexaxim : Product information (PDF/1.46 MB)

Contents

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Hexaxim: Withdrawal of the Article 58 scientific opinion - Public statement (PDF/131.71 KB)

Hexaxim-H-W-2495-P46-021 : Assessment Report (PDF/936.77 KB)

Hexaxim-H-W-2495-P46-004 : Assessment Report (PDF/2.89 MB)

Hexaxim-H-W-2495-P46-006 : Assessment Report (PDF/1.46 MB)

Hexaxim-H-W-2495-P46-015 : Assessment Report (PDF/1.13 MB)

Hexaxim : Procedural steps taken and scientific information after opinion (PDF/1.31 MB)

Hexaxim : Public assessment report (PDF/1.98 MB)

Hexaxim : All presentations (PDF/600.85 KB)

CHMP summary of positive opinion for Hexaxim (PDF/623.67 KB)

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