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INDUSTRY:

Pharma

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Regulatory & Legal

TITLE:

EMA: CHMP adopted a positive opinion recommending a change to terms of MA for Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide) tablets (150 mg/ 150 mg/ 200 mg/ 10 mg) from Gilead Sciences International Ltd.

BRIEF:

EMA: CHMP adopted a positive opinion recommending a change to terms of MA for Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide) tablets (150 mg/ 150 mg/ 200 mg/ 10 mg) from Gilead Sciences International Ltd. Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir, as follows: - In adults and adolescents aged from 12 years and with body weight at least 35 kg - In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to resistance or toxicities. (ATC code: J05AR)

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