Hexaxim H-W-2495

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Name of the medicinal productHexaxim
Opinion holder

Sanofi Pasteur

14 Espace Henry Vallee
69007 Lyon

Active substancediphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin / poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) / hepatitis-B surface antigen / Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein
International non-proprietary name or common namediphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Pharmacotherapeutic groupBacterial and viral vaccines combined 
ATC codeJ07CA09
Therapeutic indicationHexaxim 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.
Orphan-medicinal-product designation dateNot applicable


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Document(s) Language Status First published Last updated Effective Date
Hexaxim-H-W-2495-P46-021 : Assessment Report (English only) adopted 2017-05-04    
Hexaxim : Summary for the public (English only)   2012-12-04 2016-06-14  
Hexaxim : All authorised presentations (English only)   2012-12-04    
Hexaxim : Assessment report (English only) adopted 2012-12-04    
Hexaxim : Assessment report - Variation (English only) adopted 2015-09-18    
Hexaxim-H-W-2495-P46-006 : Assessment Report (English only) adopted 2016-04-25    
Hexaxim-H-W-2495-P46-015 : Assessment Report (English only) adopted 2016-04-11    
Hexaxim-H-W-2495-P46-004 : Assessment Report (English only) adopted 2016-06-03    
CHMP summary of positive opinion for Hexaxim (English only) adopted 2012-06-22    
Hexaxim : Procedural steps taken and scientific information after opinion (English only)   2013-01-18 2018-02-01  

Product Information* 08/12/2017 Hexaxim-H-W-2495 IG/0869

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Document(s) Language Status First published Last updated Effective Date
Hexaxim : Product information (English only)   2012-12-04 2018-02-01  

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*This document includes:

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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