Product Dossier
Audenz
Product Dossier for Audenz (Influenza virus haemagglutinin, Seqirus). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Seqirus
- Active ingredient: Influenza virus haemagglutinin
- Therapeutic area: Infectious Disease
- Related brand: Celldemic
- Related brand: INFLUVAC
- Related brand: FLUCELVAX
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Audenz is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.
Approved indications
— Active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.
Key safety warnings
Audenz is an adjuvanted cell-based influenza pandemic preparedness vaccine that demonstrated adequate immunogenicity and an acceptable safety profile across all age groups.
Regulatory history
Audenz received TGA approval on 2025-06-04 for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic. The product was first listed on the ARTG on 2025-06-11 as ARTG 446671, a pandemic influenza vaccine H5N1 (surface antigen, inactivated, adjuvanted) suspension for injection in prefilled syringe without needle.