COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale «Polioinfanrix».
Estratto provvedimento UPC/II/594 del 21 ottobre 2008
Specialita' medicinale: POLIOINFANRIX.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: GLAXOSMITHKLINE S.p.a.
Numero procedura mutuo riconoscimento: FR/H/0251/002/II/026.
Tipo di modifica: modifica relativa al processo di produzione del prodotto finito.
Modifica apportata: eliminazione del «potency test» in-vivo per gli antigeni IPV.
I lotti gia' prodotti, possono essere...
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