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Vaxelis
Published
Product name
Vaxelis
Active ingredient
Diphtheria toxoid, Haemophilus influenza type B polyribose ribitol phosphate, hepatitis B surface antigen, Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, Pertussis toxoid, Poliovirus and Tetanus toxoid
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Vaxelis (DTPa5 HB IPV Hib) was approved for the following therapeutic use:
Vaxelis (DTPa5 HB IPV Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
The use of Vaxelis should be in accordance with official recommendations.
How this medicine works
Vaxelis induces the production of antibodies against diphtheria, tetanus, pertussis, hepatitis B, poliovirus and invasive diseases caused by Haemophilus influenzae type b.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Vaxelis was considered favourable for the therapeutic use approved.
Sponsor