COMUNICATO - Variazione di tipo II all''autorizzazione secondo procedura di mutuo riconoscimento del medicinale «Irinotecan Kabi». (10A13659)
Estratto determinazione V & A.PC/II/744 del 25 ottobre 2010
Specialita' medicinale: IRINOTECAN KABI.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare AIC: Fresenius Kabi Oncology PLC.
N° procedura mutuo riconoscimento: UK/H/1149/001/II/022.
Tipo di modifica: aggiornamento del sistema di farmacovigilanza.
Modifica apportata: aggiornamento della descrizione dettagliata del sistema di farmacovigilanza (DDPS).
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