DENCOVIR (Alphapharm Pty Ltd)
Product name
DENCOVIR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
emtricitabine, tenofovir alafenamide fumarate
Registration type
New generic medicine
Indication
Treatment of HIV-1 Infection
DENCOVIR is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DENCOVIR (see Section 5.1 PHARMACODYNAMIC PROPERTIES).
HIV-1 Pre-Exposure Prophylaxis
DENCOVIR is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.