EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy

The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. http://processandproduction.pharmaceutical-business-review.com/news/ema-validates-gileads-chronic-hepatitis-c-regimen-230117-5721592