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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After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.
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.