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L'EMA ha avviato la valutazione del vaccino russo Sputnik V. Lo ha reso noto giovedì, attraverso un comunicato, la stessa Agenzia per i farmaci dell'Unione Europea. Nella nota di stampa si precisa che a presentare domanda per l'UE è stata la filiale tedesca del gruppo farmaceutico russo R-Pharm.
Vaccino Sputnik, ecco i dati delle analisi
Telegiornale 02.02.2021, 21:00
La decisione di avviare la procedura in tempo reale, si aggiunge, si fonda sugli esiti di studi di laboratorio e studi clinici sugli adulti. La revisione proseguirà fino a quando non saranno disponibili prove sufficienti per la domanda formale di autorizzazione all'immissione in commercio.
L'EMA non è in grado di prevedere tempistiche generali, ma indica che "dovrebbe richiedere meno tempo del normale per valutare un'eventuale domanda, a causa del lavoro svolto durante la revisione progressiva". L'organismo comunicherà ulteriormente quando sarà stata presentata la domanda di autorizzazione all'immissione in commercio per il vaccino. Mosca si dice in grado di fornire vaccini per 50 milioni di europei.
Red.MM/ARi
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