PAXLOVID (Pfizer Australia Pty Ltd)
Product name
PAXLOVID
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
35 (255 working days)
Active ingredients
nirmatrelvir; ritonavir
Registration type
NCE/NBE
Indication
PAXLOVID (film-coated tablet) has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death (see section 5.1 Pharmacodynamic properties, clinical trials).
The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the efficacy and safety data from ongoing clinical trials and post-market assessment.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration