EMA Endorses Dexamthasone for COVID-19

After reviewing the results of the RECOVERY study arm involving use of dexamethasone in the treatment of hospitalized COVID-19 patients, the European Medicines Agency (EMA) has concluded that dexamethasone can be considered a treatment option for patients requiring oxygen therapy (from supplemental oxygen to mechanical ventilation). EMA is endorsing the use of dexamethasone in adults and adolescents (from 12 years of age and weighing at least 40 kg) who require supplemental oxygen therapy. Dexamethasone can be taken by mouth or given as an injection or infusion (drip) into a vein, with the recommended dose in adults and adolescents being 6 milligrams once a day for up to 10 days. Companies that market dexamethasone can request this new use to be added to their product’s license by submitting an application to the concerned regulatory authorities in their country or to EMA. The review was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP)

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