Hexaxim H-W-2495

Name of the medicinal productHexaxim
Opinion holder

Sanofi Pasteur

14 Espace Henry Vallee
69007 Lyon
France

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

*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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