ASTRAZENECA S.P.A. -
Estratto comunicazione notifica regolare V &
A Tipo di modifica: Modifica stampati Codice Pratica N. C1B/2012/3139 Medicinale: SYMBICORT Codice farmaco: 035194214, 035194226, 035194238, 035194240, 035194253, 035194012, 035194048, 035194036, 035194024, 035194051, 035194063, 035194087, 035194075, 035194099, 035194101. MRP N. SE/H/0229/01-02/IB/061 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...
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