COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Somatoline». (13A04240)
Estratto determinazione V &
A 715 del 3 maggio 2013 Medicinale: SOMATOLINE Titolare AIC: SOCIETA' ITALO BRITANNICA L. MANETTI - H. ROBERTS &
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PER AZIONI con sede legale e domicilio fiscale in VIA PELLICCERIA, 8, 50123 - FIRENZE (FI) (codice fiscale 00770540151) Variazione AIC: B.I.a.2.b Modifiche nel procedimento di fabbricazione della sostanza attiva - Modifica sostanziale nel procedimento di fabbricazione della sostanza attiva, suscettibile di avere un impatto significativo sulla qualita', la sicurezza o l'efficacia del medicinale 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 corrispondente metodo di prova B.I.b.1.d 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 - Soppressione di un parametro di specifica non significativo (ad esempio soppressione di un parametro obsoleto) B.I.b.1.f 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 - Modifica al di fuori della categoria di limiti di specifiche per il principio attivo B.I.b.2.a Modifica nella procedura di prova del principio attivo o delle materie prime, reattivi o sostanze intermedie utilizzati nel procedimento di fabbricazione del principio attivo - Modifiche minori di una procedura di prova approvata B.I.d.1.a.1 Modifica del periodo di ripetizione della prova/periodo di stoccaggio o delle condizioni di stoccaggio della sostanza attiva quando non vi e' certificato di conformita' alla farmacopea europea che copre il periodo di ripetizione della prova nel quadro del fascicolo approvato -...
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