COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Fluarix Tetra». (16A08490)
Estratto determina VMB n. 1940/2016 del 22 novembre 2016 E' autorizzata la seguente variazione: presentazione dei dati derivanti dallo studio Zoster-004 (117036), condotto per valutare l'immunogenicita' e la sicurezza del vaccino per l'herpes. Tale studio e' stato condotto per ottemperare ad un commitment dato dal PEI nell'ambito della procedura registrativa di D-QIV (febbraio 2013), relativamente al medicinale FLUARIX TETRA ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: DE/H/1939/01/II/25. Titolare A.I.C.: GlaxosmithKline Biologicals S.A. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio...
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