COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Tazocin» (17A06757)
Estratto determina AAM/PPA n. 866 dell'8 settembre 2017 Autorizzazione delle variazioni: variazioni di tipo II: C.I.4) una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, e Variazione di tipo IB, relativamente al medicinale TAZOCIN. Codici pratica: VN2/2016/341;
VN2/2016/149;
VN2/2015/248;
VN2/2015/503;
N1B/2015/6352. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto del foglio illustrativo e delle etichette, relativamente al medicinale «Tazocin», nella forma e confezione sottoelencata: A.I.C. n. 028249023 - «2 g + 0,250 g/4 ml polvere e solvente per soluzione iniettabile per uso intramuscolare» 1 flaconcino polvere + 1 fiala solvente 4 ml. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Pfizer Limited con sede legale e domicilio in Ramsgate Road - Sandwich, Kent CT13 9NJ (Regno Unito). Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determinazione al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo e all'etichettatura. 2. 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...
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