COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Octaplas» (19A08098)
Estratto determina AAM/PPA n. 998/2019 del 6 dicembre 2019 Autorizzazione delle variazioni: C.I.3.b) - Modifica dei paragrafi 2, 4.2, 4.4, 4.8, 5.1 del riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo, a seguito della conclusione della procedura del Pediatric Worksharing SE/W/0028/pdWS/001, relativamente alla specialita' medicinale OCTAPLAS (A.I.C. n. 034540) nella seguente forma e confezione autorizzata all'immissione in commercio: A.I.C. n. 034540017 - «soluzione per infusione» sacca 200 ml. Gli stampati corretti e autorizzati sono allegati alla determina di cui al presente estratto. Titolare A.I.C.: Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. Codice pratica: VN2/2019/54. 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 alle etichette. 2. 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 nella...
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