CHMP gives positive opinion on marketing authorization variation for Veklury

The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending a change to the terms of the marketing authorization for the medicinal product Veklury. The marketing authorization holder for this medicinal product is Gilead (GILD) Sciences Ireland UC. The CHMP adopted an extension to an existing indication to include treatment of children of at least 4 weeks of age and weighing at least 3 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.