APO-TENOFOVIR/EMTRICITABINE, TENOFOVIR/EMTRICITABINE APOTEX (Apotex Pty Ltd)
Product name
APO-TENOFOVIR/EMTRICITABINE, TENOFOVIR/EMTRICITABINE APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
26 working days (255)
Active ingredients
emtricitabine; tenofovir disoproxil fumarate
Registration type
EOI
Indication
Generic medicine
APO-TENOFOVIR/EMTRICITABINE 300/200 and TENOFOVir/EMTRICITABINE 300/200 APOTEX is now also indicated, in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.