COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Priorix Tetra» (11A01396)
Estratto determinazione V & A.PC/II/8 del 18 gennaio 2011
Specialita' medicinale: Priorix Tetra.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento.
Titolare AIC: GLAXOSMITHKLINE S.P.A.
N. Procedura Mutuo Riconoscimento: DE/H/0468/001-002/II/019.
Tipo di modifica: Aggiornamento metodica chimico/farmaceutica.
Modifica apportata: Aggiornamento delle specifiche del materiale di partenza e del QC test program «amminoacidi per iniezione».
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