COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Decadron», con conseguente modifica degli stampati. (18A04640)
Estratto determina AAM/PPA n. 596/2018 del 18 giugno 2018 L'autorizzazione all'immissione in commercio del medicinale: DECADRON. Confezioni: 014729014 «0,5 mg compresse» 10 compresse;
014729038 «0,75 mg compresse» 10 compresse;
014729077 «4 mg/1 ml soluzione iniettabile» fiala da 1 ml;
014729089 «8 mg/2 ml soluzione iniettabile» fiala da 2 ml;
014729127 «4 mg/1 ml soluzione iniettabile» 3 fiale da 1 ml;
014729139 «8 mg/2 ml soluzione iniettabile» 3 fiale da 2 ml;
014729141 «2 mg/ml gocce orali soluzione» 1 flacone da 10 ml;
014729154 «2 mg/ml gocce orali soluzione» 1 flacone da 30 ml. Titolare A.I.C.: I.B.N. Savio S.r.l. Procedura nazionale, con scadenza il 19 giugno 2017 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del riassunto delle caratteristiche del prodotto, del foglio illustrativo e dell'etichettatura ed a condizione che, alla data di entrata in vigore della presente determina, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. E' inoltre autorizzata la variazione N1B/2017/1715 concernente la modifica stampati. Le modifiche devono essere apportate immediatamente per il riassunto delle caratteristiche del prodotto mentre per il foglio illustrativo ed etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determina. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua...
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