COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Piperacillina e Tazobactam Aurobindo». (18A03339)
Estratto determina PPA n. 362/2018 del 10 aprile 2018 Autorizzazioni delle variazioni. Si autorizza il seguente grouping di variazioni: B.II.b.1.f) aggiunta di un sito per la produzione del bulk di prodotto finito B.II.b.1.a) aggiunta di un sito per il confezionamento secondario del prodotto finito B.II.b.4.d) aumento della dimensione del lotto di prodotto finito massimo B.II.b.3.z) modifica del processo di fabbricazione del prodotto finito, modifica delle fasi di produzione B.II.b.5.c) eliminazione del IPC pH dopo la filtrazione sterilizzante relativamente alla specialita' medicinale PIPERACILLINA E TAZOBACTAM AUROBINDO ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento Procedura: SE/H/0844/002/II/018/G Titolare AIC...
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