COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Tribaccine». (16A08407)
Estratto determina AAM/VMB n.1839 /2016 Procedura Europea n. DK/H/0143/002/II/047. Variazione di tipo II: B.I.a.2.c). E' autorizzata la seguente variazione: modifica dei criteri adottati per stabilire la durata delle quattro colonne cromatografiche utilizzate nel processo di produzione del tossoide della pertosse, sia in termini di numero di cicli che di periodi di tempo. Relativamente al medicinale TRIBACCINE ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Titolare A.I.C.: Statens Serum Institut Codice S.I.S 3804 Smaltimento scorte I...
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