COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Fluarix». (16A08487)
Estratto determina PPA n. 1921/2016 del 18 novembre 2016 Autorizzazione della variazione relativamente al medicinale FLUARIX. E' autorizzata la seguente variazione: Aggiornamento del Risk Management Plan, versione 4.0 relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: DE/H/0124/001/II/113. 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 ai sensi dell'art. 1...
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