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.