CIPLA TENOFOVIR + EMTRICITABINE 300/200, TENOEMTRICIP 300/200, TENVIR EMTRI 300/200 (Cipla Australia Pty Ltd)
Product name
CIPLA TENOFOVIR + EMTRICITABINE 300/200, TENOEMTRICIP 300/200, TENVIR EMTRI 300/200
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 working days (225)
Active ingredients
emtricitabine; tenofovir disoproxil fumarate
Registration type
New generic medicine
Indication
Treatment of HIV-1 infection
CIPLA TENOFOVIR + EMTRICITABINE 300/200 (film coated tablet) is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.
Pre-exposure prophylaxis
CIPLA TENOFOVIR + EMTRICITABINE 300/200 is indicated in combinatin 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.