ASTRAZENECA S.P.A. -
Estratto comunicazione notifica regolare V &
A Codice Pratica N. C1B/2012/3138 Medicinale: SYMBICORTMITE Codice farmaco: 035603012, 035603036, 035603024, 035603048, 035603051, 035603063, 035603075, 035603087, 035603099, 035603101. MRP N. SE/H/0230/01/IB/053 Tipologia variazione oggetto della modifica: IB foreseen, C.1.3. Modifica apportata: Modifica stampati in seguito al worksharing pediatrico che definisce la combinazione di budesonide e formoterolo (DE/W/046/pdWS/001, Art.45) E' autorizzata la modifica degli stampati richiesta (paragrafo 5.1 del Riassunto delle Caratteristiche del Prodotto e corrispondente paragrafo del Foglio Illustrativo) relativamente alle confezioni sopra elencate e la responsabilita' si ritiene affidata alla Azienda titolare dell'AIC. I lotti gia'...
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