ARTG Entry
Audenz
ARTG entry for Audenz (Influenza virus haemagglutinin), ARTG 446671 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Seqirus
- Active ingredient: Influenza virus haemagglutinin
- Therapeutic area: Infectious Disease
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.