COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Acido Acetilsalicilico e Vitamina C Zentiva». (17A07063)
Estratto determina AAM/PPA n. 916 del 25 settembre 2017 Codice pratica: VN2/2017/166. E' autorizzata la seguente variazione di tipo II: B.II.d.1.c Modifica dei parametri di specifica e/o dei limiti del prodotto finito - Aggiunta di un nuovo parametro di specifica alla specifica con il corrispondente metodo di prova, B.II.d.1.g Modifica dei parametri di specifica e/o dei limiti del prodotto finito - Aggiunta o sostituzione (ad esclusione dei prodotti biologici o immunologici) di un parametro di specifica con il corrispondente metodo di prova, per questioni di sicurezza o di qualita', B.II.a.3.a.1 Modifiche nella composizione (eccipienti) del prodotto finito - Modifiche del sistema di aromatizzazione o di colorazione - Aggiunta, soppressione o sostituzione, B.II.b.3.e Modifica nel procedimento di fabbricazione del prodotto finito, compreso un prodotto intermedio utilizzato per la fabbricazione del prodotto finito - Introduzione o aumento del sovradosaggio utilizzato per il principio attivo, B.II.a.3.z Modifiche nella composizione (eccipienti) del prodotto finito - Altra variazione, B.II.a.3.b.1 Modifiche nella composizione (eccipienti) del prodotto finito - Altri eccipienti - Gli adattamenti di scarsa rilevanza della composizione quantitativa del prodotto finito per quanto riguarda gli eccipienti, B.II.b.3.a Modifica nel procedimento di fabbricazione del prodotto finito, compreso un prodotto intermedio utilizzato per la fabbricazione del prodotto finito - Modifica minore nel procedimento di fabbricazione, B.II.b.5.z Modifica delle prove in corso di fabbricazione o dei limiti...
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