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Emtricitabine/Tenofovir disoproxil Zentiva recommended by EMA CHMP as generic for Truvada in HIV treatment- Zentiva
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Emtricitabine/Tenofovir disoproxil Zentiva, from Zentiva, intended for the treatment of HIV infection. It will be available as 200 mg/245 mg film-coated tablets. Emtricitabine/Tenofovir disoproxil Zentiva is a generic of Truvada which has been authorised in the EU since 21 February 2005. Studies have demonstrated the satisfactory quality of Emtricitabine/Tenofovir disoproxil Zentiva, and its bioequivalence to the reference product Truvada.