COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale 'Epaxal'
Estratto provvedimento UPC/II/3227 del 12 settembre 2007
Specialita' medicinale: EPAXAL.
Confezioni: autorizzata all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Berna Biotech Italia S.r.l.
Numero procedura di mutuo riconoscimento: SE/H/0111/001/II/039, 44, 45.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata: sostituzione del "test di profilo" e aggiunta di fornitori di siero fetale bovino: Biochrom AG (RI-CEP 2001-032-REV 00), SAFC Biosciences (R1-CEP 2000-387-REV 00), Moregate Biotech (R1-CEP 2000-187-REV 00), Invitrogen Corporation (R1-CEP 2000-155 REV 01) e PAA Laboratoires GmbH (R0-CEP 2001-083-REV 02).
Modifiche minori per la procedura del test di in attivazione del pool inattivato del virus dell'epatite A.
Estensione del periodo di validita' da...
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