TENOFOVIR EMTRICITABINE SANDOZ (Sandoz Pty Ltd)
Product name
TENOFOVIR EMTRICITABINE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
172 (255 working days)
Active ingredients
emtricitabine; tenofovir disoproxil succinate
Registration type
New generic medicine
Indication
Treatment of HIV-1 infection
TENOFOVIR, EMTRICITABINE SANDOZ (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
TENOFOVIR, EMTRICITABINE SANDOZ is 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 (see section 5.1 Pharmacodynamic properties, Clinical trials).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine