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EMA approval · 2026-03-31

EMA Authorised: Vaxelis (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3;hepatitis B surface antigen produced in yeast cells;poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.) — MCM Vaccine B.V.

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Summary

The EMA has authorised Vaxelis, a combination vaccine containing diphtheria and tetanus toxoids, pertussis antigens, hepatitis B surface antigen, Haemophilus in…

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Diseases / indications

Drugs mentioned

  • Vaxelis (DTaP5-HBV-IPV-Hib)

Snippet

Status: Authorised. Therapeutic area: Meningitis, Haemophilus;Poliomyelitis;Tetanus;Diphtheria;Whooping Cough;Hepatitis B. MAH: MCM Vaccine B.V.. Decision date: 26/03/2026