Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Section A: Pre-market registration applications referred for advice
At this meeting, the committee’s advice was sought on 2 applications under evaluation by the TGA. The applications included:
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area |
|---|---|---|
| Type A (new chemical entity) | ||
| PF07321332 / ritonavir (PAXLOVID) | Pfizer Australia Pty Ltd | For treatment of COVID-19 |
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). Please note that there is a delay from when an application was considered at ACM and the publication of the AusPAR. Browse all AusPARs.
Further information
For further information visit the Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.