COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale uso umano «Thymoglobuline» (16A08383)
Estratto determina AAM/PPA n. 1849/2016 del 14 novembre 2016 E' autorizzata la seguente variazione di tipo II: B.I.a.2.b Modifiche nel procedimento di fabbricazione del principio attivo - Modifica sostanziale nel procedimento di fabbricazione del principio attivo, tale da avere un impatto significativo sulla qualita', la sicurezza o l'efficacia del medicinale, relativamente al medicinale THYMOGLOBULINE, nelle forme e confezioni: A.I.C. n. 033177027 - «5 mg/ml polvere per soluzione per infusione» 1 fiala da 10 ml;
aggiornamento della sezione 3.2.A.1 del dossier di registrazione riguardo al sito produttivo del medicinale «Thymoglobuline»: Genzyme Polyclonals SAS, 23 boulevard Chambaud de la Bruyere, 69007 Lyon France, da sito monoprodotto a sito multi prodotto, in cui viene prodotto e purificato un altro farmaco in sviluppo basato su un vettore...
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