COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Priorix Tetra». (16A07445)
Estratto determina V&A n. 1557/2016 del 28 settembre 2016 E' autorizzata la seguente variazione: C.I.13) Presentazione di uno studio clinico condotto nel contesto di un post authorization measure per confermare l'uso di nuovi plunger stopper e tip cap relativamente alla specialita' medicinale PRIORIX TETRA ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: DE/H/0468/001-002/II/061. Titolare A.I.C.: GlaxoSmithKline S.p.a. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in etichetta...
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