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APRETUDE (ViiV Healthcare Pty Ltd)
Product name
APRETUDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
144 (255 working days)
Active ingredients
cabotegravir sodium, cabotegravir
Registration type
EOI
Indication
APRETUDE is indicated in at-risk adults and adolescents (at least 12 years of age) and weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
APRETUDE tablets may be used as an oral lead-in to assess tolerability of cabotegravir prior to administration of cabotegravir injections or as short-term oral PrEP in individuals who will miss planned dosing with cabotegravir injections.
Individuals must have a documented negative HIV-1 test prior to initiating APRETUDE for HIV-1 PrEP.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available