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Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
17 February 2022
AstraZeneca’s Marketing Authorisation Application (MAA) for nirsevimab has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the prevention of medically attended lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season. Nirsevimab is being developed by AstraZeneca in collaboration with Sanofi.
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