Hexaxim H-W-2495

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Name of the medicinal productHexaxim
Opinion holderSanofi Pasteur S.A.
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 : Summary for the public (English only)   04/12/2012 14/06/2016  
Hexaxim : All authorised presentations (English only)   04/12/2012    
Hexaxim : Assessment report (English only) adopted 04/12/2012    
Hexaxim : Assessment report - Variation (English only) adopted 18/09/2015    
Hexaxim-H-W-2495-P46-006 : Assessment Report (English only) adopted 25/04/2016    
Hexaxim-H-W-2495-P46-015 : Assessment Report (English only) adopted 11/04/2016    
Hexaxim-H-W-2495-P46-004 : Assessment Report (English only) adopted 03/06/2016    
CHMP summary of positive opinion for Hexaxim (English only) adopted 22/06/2012    
Hexaxim : Procedural steps taken and scientific information after opinion (English only)   18/01/2013 26/05/2016  

Product Information* 28/04/2016 Hexaxim-H-W-2495 WS/0907

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Document(s) Language Status First published Last updated Effective Date
Hexaxim : Product information (English only)   04/12/2012 26/05/2016  

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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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