Iodosan S.P.A.
Modifica Secondaria di un'Autorizzazione all'Immissione in Commercio di Specialita' Medicinale per Uso Umano. Modifica apportata ai sensi del Decreto Legislativo 29 dicembre 2007, n. 274.
Titolare: Iodosan S.p.A. - Via Zambeletti s.n.c. - Baranzate (MI) Medicinale: GOLA ACTION - Confezione: '3 mg + 1 mg compresse orosolubili senza zucchero' 20 compresse - 033501014
Modifica apportata ai sensi del Regolamento (CE) N. 1084/2003:
Codice Pratica N1B/09/977 - Modifica Tipo IB n. 37b e conseguente 38c - Aggiunta del parametro di prova 'Impurezze benzidamina:
Impurezza A, Impurezza B, Impurezza C, Benzidamina-N-ossido, ogni singola impurezza non nota, Impurezze totali' col relativo metodo HPLC impiegato per la determinazione alle specifiche al rilascio ed al termine del periodo di validita' del prodotto finito.
Contestualmente si autorizza la sostituzione del metodo...
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