COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Carboplatino AHCL» (18A06802)
Estratto determina AAM/PPA n. 858/ 2018 del 2 ottobre 2018 Si autorizza la seguente variazione Tipo II, C.I.2b): Aggiornamento degli stampati in linea con il medicinale di riferimento e per implementare l'esito della procedura PSUSA/00000559/201601, relativamente alla specialita' medicinale CARBOPLATINO AHCL, nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura europea di mutuo riconoscimento: A.I.C. n.: 039263013 - «10 mg/ml concentrato per soluzione per infusione» 1 flaconcino di vetro da 5 ml;
039263025 - «10 mg/ml concentrato per soluzione per infusione» 1 flaconcino di vetro da 15 ml;
039263037 - «10 mg/ml concentrato per soluzione per infusione» 1 flaconcino di vetro da 45 ml;
039263049 - «10 mg/ml concentrato per soluzione per infusione» 1 flaconcino di vetro da 60 ml. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Titolare AIC: Accord Healthcare Limited (Codice SIS 3029). Numero procedura: UK/H/1126/001/II/032. Stampati 1. Il titolare dell'Autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina, 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 successiva modificazione e integrazioni 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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