COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vaxigrip Tetra» (18A03342)
Estratto determina PPA n. 365/2018 del 10 aprile 2018 Autorizzazione delle variazioni. Si autorizza il seguente worksharing: B.II.b.2.b - Aggiunta del sito Sanofi Winthrop Industrie (Le Trait) per i test di controllo di qualita' del prodotto finito del vaccino influenzale quadrivalente VAXIGRIP TETRA relativamente alla specialita' medicinale «Vaxigrip Tetra» ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento Procedura: DE/H/1949/001/II/008 Titolare AIC: Sanofi Pasteur Europe Attuazione In ottemperanza alla determinazione del direttore generale del 7 dicembre 2016, DG/1496/2016, relativa all'applicazione degli articoli 23 e 24 del regolamento (CE) n. 1234/2008, la ditta attua la modifica dopo trenta giorni a partire dalla data di fine procedura...
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