COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Voltaren» (17A02074)
Estratto determina AAM/PPA n. 190/2017 del 20 febbraio 2017 E' autorizzato il seguente grouping di variazioni: A.7 Soppressione dei siti di fabbricazione per un principio attivo, un prodotto intermedio o finito, un sito di confezionamento, un fabbricante responsabile del rilascio dei lotti, un sito in cui si svolge il controllo dei lotti o un fornitore di materia prima, di un reattivo o di un eccipiente, B.I.d.1.a.1 Modifica del periodo di ripetizione della prova/periodo di stoccaggio o delle condizioni di stoccaggio del principio attivo quando non vi e' un certificato di conformita' alla farmacopea europea che copre il periodo di ripetizione della prova nel quadro del fascicolo approvato - Periodo di ripetizione della prova/periodo di stoccaggio - Riduzione, B.I.a.2.a Modifiche nel procedimento di fabbricazione del principio attivo - Modifiche minori nel procedimento di fabbricazione del principio attivo, B.I.b.1.c Modifica dei parametri di specifica e/o dei limiti del principio attivo, di una materia prima, di una sostanza intermedia o di un reattivo utilizzato nel procedimento di fabbricazione del principio attivo - Aggiunta di un nuovo parametro di specifica alla specifica con il metodo di prova corrispondente, B.I.a.1 z) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea - Altra variazione, B.I.b.1 z) Modifica dei parametri di specifica e/o dei limiti del principio attivo...
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