Notice for cabotegravir (as sodium) and cabotegravir (ViiV Healthcare Pty Ltd)
Active ingredients
cabotegravir (as sodium) and cabotegravir
Sponsor
Date of review outcome
Lapse date
Type
Priority review
Indication
Cabotegravir prolonged release suspension for injection: Pre Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg.
Cabotegravir oral film-coated tablet: Short term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg. Cabotegravir tablets may be used as:
oral lead-in to assess tolerability of cabotegravir prior to administration of cabotegravir injection.
oral PrEP in individuals who will miss planned dosing with cabotegravir injection
Cabotegravir oral film-coated tablet: Short term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals weighing at least 35 kg. Cabotegravir tablets may be used as:
oral lead-in to assess tolerability of cabotegravir prior to administration of cabotegravir injection.
oral PrEP in individuals who will miss planned dosing with cabotegravir injection
Therapeutic area
Infectious diseases