COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Sandimmun Neoral» (15A05394)
Estratto determina V&A n. 1233/2015 del 19 giugno 2015 E' autorizzata la seguente variazione: sottomissione di un Clinical Study Report e di documentazione aggiuntiva relativa allo studio COLO400A2430 relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Procedura: DE/H/4019/001-004/II/004 Tipologia della variazione: C.I.13) Titolare A.I.C.: Novartis Europharm LTD. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in etichetta ai...
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