COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Frobenpret» (19A08069)
Estratto determina AAM/PPA n. 1003 del 9 dicembre 2019 Autorizzazione delle variazioni: variazioni 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.e) Modifica dei parametri di specifica e/o dei limiti del prodotto finito. Modifica al di fuori dei limiti di specifica approvati, relativamente al medicinale FROBENPRET. Codice pratica: VN2/2019/143. Si autorizza introduzione di un nuovo parametro di specifica con il corrispondente metodo di prova al termine del periodo di validita' del prodotto finito, ampliamento dei limiti di specifica approvati per le impurezze totali al termine del periodo di validita' del prodotto finito - relativamente ai medicinale «Frobenpret», nelle forme e confezioni autorizzate. Titolare A.I.C...
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