LAGEVRIO (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
LAGEVRIO
Date registered
Evaluation commenced
Decision date
Approval time
104 (255 working days)
Active ingredients
molnupiravir
Registration type
NCE/NBE
Indication
LAGEVRIO (capsule) has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death (see section 5.1 Pharmacodynamic properties - clinical trials).
The decision to approve this indication has been made on the basis of the analysis of efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration