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CHMP recommends a change to the marketing authorisation for Veklury, a treatment for COVID -19. - Gilead Sciences
On 10 December 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Veklury. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.
The CHMP adopted a change to the indication as follows: "Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)".
Condition: Coronavirus/COVID-19 Infection
Type: drug