COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aurantin» (20A05217)
Estratto determina AAM/PPA n. 529/2020 del 21 settembre 2020 Autorizzazione del grouping di variazioni, descrizione del medicinale, attribuzione nuovo numero di A.I.C. in sostituzione della confezione precedentemente autorizzata: e' autorizzato il seguente grouping di variazioni relative al medicinale AURANTIN (A.I.C. n. 028823): sostituzione del produttore di prodotto finito da Actavis Italy S.p.a. a Pfizer Puurs Belgio, per tutte le fasi di produzione, controllo e rilascio lotti, confezionamento primario e secondario, e conseguenti modifiche del processo di produzione e dei controlli in-process, aumento della dimensione del lotto, ampliamento, rafforzamento, aggiunta e eliminazione dei limiti di alcune specifiche del prodotto finito, aggiunta e modifica di alcuni metodi del prodotto finito, ampliamento della durata di conservazione del prodotto finito da trenta a trentasei mesi E' autorizzata l'immissione in commercio della confezione: «250 mg/5 ml soluzione iniettabile» 5 flaconcini in vetro contenenti 5 ml di soluzione - A.I.C.n. 028823021 (base 10) - 0VHMHF (base 32). Forma farmaceutica: soluzione iniettabile. Principio attivo: fenitoina sodica. In sostituzione della confezione: A.I.C. n. 028823019 - «250 mg/5 ml soluzione iniettabile» 5 fiale in vetro da 5 ml che viene contestualmente revocata. Titolare A.I.C.: Pfizer Established Medicine Italy S.r.l. (codice fiscale 03009550595). Codice pratica: VN2/2019/38. Stampati Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come precedentemente autorizzati da questa amministrazione, con le sole modifiche necessarie per l'adeguamento alla presente determina. In ottemperanza all'art. 80, commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni, il foglio...
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