EMA Endorses Use Of Dexamethasone In COVID-19
The Move Should Speed Up EU National Approvals
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.
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The European Medicines Agency's special review process that was used to help EU member states issue emergency use approvals for dexamethasone in COVID-19 patients is now being applied to two antibody combinations from Regeneron/Roche and Lilly.
The withdrawal of the marketing authorization application for Dexamethasone Taw as a treatment for COVID-19 patients was revealed today in the January meeting agenda of the European Medicines Agency’s human medicines committee, the CHMP.
The agility, flexibility and transparency that the European Medicines Agency has adopted during the development and assessment of COVID-19 products will have to continue after treatments and vaccines are on the market, says the soon-to-be new head of the agency, Emer Cooke.