Section A: Premarket registration applications
At this meeting the committee provided advice on one application under evaluation by the TGA.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Applications for a 'new vaccine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A) | |||
influenza virus haemagglutinin (AUDENZ) | Seqirus Pty Ltd | Prophylaxis of influenza in an officially declared pandemic situation in persons aged 6 months of age and older. | |
influenza virus haemagglutinin (CELLDEMIC) | Seqirus Pty Ltd | For active immunisation in persons from 6 months of age, to prevent influenza disease caused by the influenza A virus. | |
The date of commencement of the evaluation of the application is available at Prescription medicines: Applications under evaluation.
Further details of the ACV discussion and advice associated with items may be released within the Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACV was not asked to provide advice on a post-market or safety issue.
Further information
For further information on the Advisory Committee on Vaccines, please visit Advisory Committee on Vaccines (ACV) or contact the ACV Secretary by email: ACV@health.gov.au.