COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio di taluni medicinali per uso umano (18A02030)
Estratto determina PPA n. 246/2018 del 15 marzo 2018 Autorizzazione delle variazioni: B.I.a.1.e - Registrazione di un ulteriore nuovo impianto per la produzione di idrossido di alluminio nel sito di GSK Vaccines di Marburg in Germania. Modifica del processo e dei macchinari per consentire l'aumento nella capacita' produttiva del 50%;
B.I.b.1.c - Modifica della specifica per idrossido di alluminio in conformita' con la farmacopea europea (idrossido di alluminio idrato, adsorbito);
B.1.a.2.c - Introduzione di un passaggio di ri-processazione nell'ambito della procedura di inattivazione, parte del processo produttivo del bulk monovalente del polio virus inattivato, relativamente alle specialita' medicinali BOOSTRIX - INFANRIX - POLIOBOOSTRIX - POLIOINFANRIX nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento...
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