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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 |
|---|---|---|---|
| Application for a 'new indication', or additional therapeutic use, for an already approved vaccine (Application Type C) | |||
recombinant respiratory syncytial virus pre-fusion F protein (AREXVY) | GlaxoSmithKline Australia Pty Ltd
| For the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV). | |
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.