At this meeting, the committee provided advice on 2 applications under evaluation by the TGA, as below.
Active ingredient (TRADENAME)
Applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A)
tixagevimab and cilgavimab (EVUSHELD)
AstraZeneca Pty Ltd
For treatment / prophylaxis of COVID-19
The committee also provided advice on:
One application for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see: <https://www.tga.gov.au/resources/auspar>
For further information on the Advisory Committee on Medicines, please visit:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.