COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Noradrenalina Tartrato Aguettant». (20A03070)
Estratto determina AAM/PPA n. 280/2020 del 27 maggio 2020 Si autorizza la seguente variazione tipo II, C.I.4), relativamente al medicinale NORADRENALINA TARTRATO AGUETTANT: modifica degli stampati, par. 1, 2, 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1, 6.5, 6.6 e 8 del riassunto delle caratteristiche del prodotto (RCP), corrispondenti sezioni del foglio illustrativo ed etichettatura, per introduzione di nuovi effetti indesiderati;
adeguamento alla Linea guida in tema di eccipienti;
adeguamento al QRD Template, nella versione corrente;
modifiche minori. Confezioni A.I.C. n.: 043465018 - «0,5 mg/ml soluzione per infusione» 1 flaconcino in vetro da 50 ml;
043465020 - «0,5 mg/ml soluzione per infusione» 10 flaconcini in vetro da 50 ml;
043465032 - «0,5 mg/ml soluzione per infusione» 25 flaconcini in vetro da 50 ml. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Titolare A.I.C.: Laboratoire Aguettant. Numero procedura: DE/H/6324/001-002/II/004. Codice pratica: VC2/2019/191. 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 successive modificazioni ed 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 tedesca. Il titolare...
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