COMUNICATO - Rinnovo dell''autorizzazione all''immissione in commercio, secondo procedura nazionale, del medicinale «Ceftazidima Teva» con conseguente modifica stampati. (11A15032)
Estratto provvedimento FV/136 del 28 ottobre 2011
Medicinale: CEFTAZIDIMA TEVA.
Confezioni:
036022022 1G/3ML polvere e solvente per soluzione iniettabile per uso intramuscolare, 1 flacone polvere + 1 fiala solvente da 3 ml;
036022034 1G/10ML polvere e solvente per soluzione iniettabile per uso endovenoso, 1 flacone polvere + 1 fiala solvente da 10 ml;
036022046 2G polvere per soluzione per infusione, 1 flacone polvere.
Titolare AIC: TEVA ITALIA S.r.l.
Procedura nazionale.
Con scadenza 5 maggio 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 60 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 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 tedesca. Il...
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