Hexaxim H-W-2495
| Name of the medicinal product | Hexaxim |
| Opinion holder |
Sanofi Pasteur 14 Espace Henry Vallee |
| Active substance | diphtheria 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 name | diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) |
| Pharmacotherapeutic group | Bacterial and viral vaccines combined |
| ATC code | J07CA09 |
| 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. |
| Orphan-medicinal-product designation date | Not applicable |
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Hexaxim-H-W-2495-P46-021 : Assessment Report (PDF/305.77 KB)
Adopted
First published: 04/05/2017
Last updated: 04/05/2017
EMA/237990/2017 -
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Hexaxim : Summary for the public (PDF/77.69 KB)
First published: 04/12/2012
Last updated: 14/06/2016
EMA/448566/2012 -
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Hexaxim : All authorised presentations (PDF/23.52 KB)
First published: 04/12/2012
Last updated: 04/12/2012 -
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Hexaxim : Assessment report (PDF/911.15 KB)
Adopted
First published: 04/12/2012
Last updated: 04/12/2012 -
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Hexaxim : Assessment report - Variation (PDF/425.44 KB)
Adopted
First published: 18/09/2015
Last updated: 18/09/2015
EMA/CHMP/329785/2015 -
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Hexaxim-H-W-2495-P46-006 : Assessment Report (PDF/607.6 KB)
Adopted
First published: 25/04/2016
Last updated: 25/04/2016
EMA/245070/2016 -
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Hexaxim-H-W-2495-P46-015 : Assessment Report (PDF/389.2 KB)
Adopted
First published: 11/04/2016
Last updated: 11/04/2016
EMA/245070/2016 -
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Hexaxim-H-W-2495-P46-004 : Assessment Report (PDF/2.26 MB)
Adopted
First published: 03/06/2016
Last updated: 03/06/2016
EMA/389260/2016 -
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CHMP summary of positive opinion for Hexaxim (PDF/46.59 KB)
Adopted
First published: 22/06/2012
Last updated: 22/06/2012
EMA/CHMP/409930/2012 -
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Hexaxim : Procedural steps taken and scientific information after opinion (PDF/291.53 KB)
First published: 18/01/2013
Last updated: 03/06/2019
*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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