COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Alburex». (18A01027)
Estratto determina AAM/PPA n. 58 del 25 gennaio 2018 Autorizzazione delle variazioni: Variazioni di tipo II: B.I.a.1), B.II.b.1), B.I.b. 2), B.II.b.2), B.II.d.2), relativamente al medicinale ALBUREX. Numero di procedura: n. DK/H/1508/001-003/II/061/G. Sono autorizzate le seguenti variazioni: introduzione del sito CSL Behring (CSLB) di Kankakee, IL, USA, per la produzione dell'intermedio Precipitato C da utilizzare per l'ulteriore processamento a prodotto finito nello stesso sito di Kankakee (USA) e nel sito CSL Behring di Berna (Switzerland);
introduzione dell'elettrodo iono-selettivo (Ion-selective electrode - ISE) quale metodo alternativo per misurare il contenuto di sodio nella soluzione di albumina dopo la diafiltrazione durante la produzione del principio attivo a CSLB, Bern, Switzerland;
introduzione del sito CSLB di Marburg, Germania, quale sito di confezionamento secondario per il prodotto finito;
introduzione del sito CSLB, Kankakee, IL, USA come sito produttivo alternativo del prodotto finito ad eccezione delle fasi di controllo e di rilascio lotti e di confezionamento secondario;
introduzione del sito CSLB di Marburg quale produttore responsabile del controllo sul...
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