COMUNICATO - Rinnovo dell''autorizzazzione all''immissione in commercio, secondo procedura nazionale, del medicinale «Gentalyn» con conseguente modifica stampati. (11A04706)
Estratto provvedimento FV/21 del 22 marzo 2011
Medicinale: GENTALYN.
Confezioni:
A.I.C. n. 020891 026 10mg/1ml soluzione iniettabile 5 fiale 1 ml;
A.I.C. n. 020891 038 20mg/2ml soluzione iniettabile 1 fiale 2 ml;
A.I.C. n. 020891 040 40mg/1ml soluzione iniettabile 1 fiala 1 ml;
A.I.C. n. 020891 014 80mg/2ml soluzione iniettabile 1 fiala 2 ml;
A.I.C. n. 020891 089 120mg/1,5l soluzione iniettabile 1 fiala 1,5 ml;
A.I.C. n. 020891 053 160mg/2ml soluzione iniettabile 1 fiala 2 ml;
A.I.C. n. 020891 065 0,1% unguento tubo 30 g;
A.I.C. n. 020891 077 0,1% crema tubo 30 g.
Titolare A.I.C.: Schering-Plough S.p.a.
Procedura nazionale con scadenza il 1° giugno 2010 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 determinazione, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti.
Le modifiche devono essere apportate immediatamente per il riassunto delle caratteristiche del prodotto, per il foglio illustrativo ed etichettatura entro centottanta giorni dall'entrata in vigore della determinazione.
In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219, e successive modificazioni ed integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio...
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