EC Approves Truvada Containing Anti-HIV Drugs Emtriva and Viread

The European Commission has granted Gilead Sciences a marketing authorization for Truvada in all 25 member states of the European Union (EU).

Truvada (emtricitabine/tenofovir disoproxil fumarate) combines the company's anti-HIV medications Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) in one tablet, taken once a day in combination with other antiretroviral agents.

In the EU, Truvada is indicated for the treatment of HIV-infected adults in combination with other antiretroviral agents. This indication is based on the demonstration of the benefit of the combination of emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy in treatment-naïve patients.

As Truvada contains emtricitabine and tenofovir disoproxil fumarate, the guidance for physicians in the Truvada Summary of Product Characteristics (SmPC) is consistent with the guidance in the SmPCs of Emtriva and Viread. A European SmPC is similar to a product's prescribing information in the U.S.