COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Paclitaxel Accord Healthcare Italia». (16A02898)
Estratto determina V&A n. 551/2016 del 23 marzo 2016 Procedura EU n.: NL/H/1444/001/II/021. Medicinale: PACLITAXEL ACCORD HEALTHCARE ITALIA. Tipo II: B.II.b.4.d. E' autorizzata la seguente variazione: modifica della dimensione del lotto di prodotto finito, per aggiunta del batch da 250.0 Kg (268.24 L). Titolare A.I.C.: Accord Healthcare Limited (Codice S.I.S. 3029). Smaltimento scorte: i lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata...
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