COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Quetiapina Zentiva» (14A03757)
Estratto determinazione V &
A/704 del 9 aprile 2014 Specialita' medicinale: QUETIAPINA ZENTIVA. Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Titolare AIC: Zentiva Italia S.r.l. Numero procedura mutuo riconoscimento: DE/H/2491/001-006/II/014. Tipo di modifica: B.1.z) Other variatin. Modifica apportata: aggiornamento del Drug Master File del produttore del principio attivo quetiapina fumarato: Matrix Laboratories Limited (da versione MLL/QHF/AP/001/04, March...
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