COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Prolastin». (13A09914)
Estratto determinazione V &
A/2091 del 25 novembre 2013 Specialita' medicinale: PROLASTIN. Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Titolare AIC: INSTITUTO GRIFOLS S.A. N. Procedura Mutuo Riconoscimento: DE/H/0472/001/II/023/G Tipo di Modifica: A.7 Soppressione dei siti di fabbricazione (anche per una sostanza attiva, un prodotto intermedio o finito, un sito di imballaggio, un fabbricante responsabile del rilascio dei lotti,un sito in cui si svolge il controllo dei lotti o un fornitore di un materiale di partenza, reattivo o eccipiente). B.II.b.2.b.3 Modifica delle modalita' di liberazione dei lotti e delle prove di controllo qualitativo del prodotto finito Sostituzione o aggiunta di un fabbricante responsabile della liberazione dei lotti Con controllo dei lotti/prove per un prodotto biologico o immunologico e uno dei metodi di prova effettuati e' un metodo biologico o immunologico o immunochimico. B.II.d.2.c Modifica della procedura di prova del prodotto finito Sostituzione di un metodo di prova biologico o immunologico o immunochimico o di un metodo che utilizza un reattivo biologico. Modifica Apportata: modifica dei siti autorizzati alle procedure di rilascio del prodotto finito e relativi testing da: Produttore responsabile per il batch release nel EEA: Grifols Deutschland GmbH Lyoner Strasse 15, 60528 Frankfurt - Germany OMCL: Paul Ehrlich Institut (PEI), Paul Ehrlich-Str 51-59- 63225 Langen Germany Batch control e testing: Catalent Pharma...
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