Section A: Premarket registration applications
At this meeting, the committee provided advice on 2 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| 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 | Provisional |
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>
Further information
For further information on the Advisory Committee on Medicines, please visit:
<https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-medicines-acm>
or contact the ACM Secretary by email: ACM@health.gov.au
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