COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Rhesonativ». (14A05567)
Estratto determinazione V &
A n. 1332/2014 del 1° luglio 2014 Numero di procedura: SE/H/0541/001/II/017/G Autorizzazione della variazione: E' autorizzata: la modifica del processo produttivo di frazionamento da: processo di frazionamento con etanolo secondo Cohn a: processo di frazionamento con etanolo secondo Kistler Nitschmann la dimensione alternativa del batch size dell'intermedio (cryo poor plasma ) modifica del wording in sezione 2.2.4 da: intermedio corrispondente a un massimo di 3000 kg a: intermedio corrispondente a un massimo di 4200 kg± 10% la modifica del batch size del prodotto finito da: ≤
5500 fiale a: ≤
20000 fiale E' autorizzata la modifica della composizione degli eccipienti del prodotto finito da: Glicina:20 mg Sodio cloruro e sodio acetato corrispondenti a sodio : 1.6 mg Acqua per preparazioni iniettabili q.b. a 1 ml a: Glicina:20 mg Polisorbato 80: 30 microgrammi Sodio cloruro e sodio acetato corrispondenti a sodio : 1.6 mg Acqua per preparazioni iniettabili q.b. a 1 ml con aggiornamento del Riassunto delle Caratteristiche del Prodotto paragrafo 6.1, del Foglio Illustrativo sezione 6 e delle Etichette sezione 3, relativamente al medicinale RHESONATIV , nelle forme e confezioni sottoelencate: 039596010 - "" 625 ul/ml soluzione iniettabile "" 1 fiala in vetro da 1ml 039596022 - "" 625 ul/ml soluzione iniettabile "" 1 fiala in vetro da 2 ml 039596034 - "" 625 ul/ml soluzione iniettabile "" 10 fiale in vetro da 2 ml Titolare AIC: Octapharma Italy S.P.A. Stampati 1. Il Titolare dell'Autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data...
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