Product Dossier
FLUBLOK
Product Dossier for FLUBLOK (Influenza haemagglutinin recombinant, Sanofi-Aventis). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by…
- Sponsor: Sanofi-Aventis
- Active ingredient: Influenza haemagglutinin recombinant
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Flublok is a recombinant influenza vaccine available as a solution for injection in syringe form. Two variants are registered: a quadrivalent formulation and a trivalent formulation containing influenza haemagglutinin recombinant 135 micrograms.
Approved indications
— Prevention of influenza in patients aged 65 years and over.
PBS listing
Flublok was recommended by the PBAC in March 2024 for the prevention of influenza in patients aged 65 years and over. No further PBS listing details are available in the provided sources.
Regulatory history
Flublok Quadrivalent was first registered on the ARTG on 13 May 2021. The PBAC recommended Flublok for the prevention of influenza in patients aged 65 years and over in March 2024. A trivalent formulation was subsequently registered on the ARTG on 9 May 2025.