COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio della specialita' medicinale 'Winrho'
Estratto provvedimento UPC/II/3117 del 30 maggio 2007
Specialita' medicinale: WINRHO.
Confezioni: autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Cangene Europe LTD.
Numero procedura mutuo riconoscimento: UK/H/0634/001-003/II/011, 01, 03.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata:
sostituzione del test kit "parvo igg-eia seikin" prodotto da Denka/Seiken (Tokio - Japan) con il test kit 2 parvovirus b19 igg" prodotto da Nova Tec Immunodiagnostica Gmbh (Dietzenbach, Germania);
sostituzione del laboratorio di analisi "Institute fur Meizinische Virologie (IMV) Der J.W. Goethe - Universitat Frankfurt/Main Germany" responsabile dei controlli virali del plasma pool con il nuovo Laboratorio: "Laboratoires Diagnostiques (LDS) 175 Stillview, Suite 155 - Pointe Claire, Quebec - Canada, H9R 4S3".
Restringimento delle specifiche del test di stabilita' di Winrho...
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