According to a press release, the drug is the result of the combination of two biological drugs (casirivimab + imdevimab). Anvisa informs that the first 72 hours will be used to screen the process and check if the necessary documents are available.
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Roche delivered 3,626 pages of data and information about the drug. If important information is missing, Anvisa can ask the laboratory. To make the assessment, Anvisa will use the technical report issued by the American authority (Food and Drug Administration – FDA).
According to information available on the Roche group’s website, the cocktail of drugs against Covid was tested on approximately 23,000 people in clinical trials conducted in February 2021. The trials were conducted on outpatients and certain hospitalized patients, including the open trial. in hospitalized patients in the UK and a trial for the prevention of covid-19.
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