COMUNICATO - Proroga dello smaltimento delle scorte del medicinale «Fixioneal» (11A05532)
Estratto provvedimento V & A.PC n. 374 dell'11 aprile 2011
Titolare AIC: Baxter SPA.
Specialita' medicinale: FIXIONEAL.
Tipologia: proroga smaltimento scorte.
Considerate le motivazioni portate da Codesta Azienda, trattandosi di formulazioni in sacca per le quali la preparazione di una nuova etichetta richiede tempi molto lunghi e, considerato che la modifica autorizzata non comporta alcun impatto sulla qualita' di prodotto finito.
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Si concede per le confezioni della specialita' medicinale «Fixioneal» autorizzate e coinvolte dalla modifica stampati, gia' immesse in commercio la dispensazione fino al totale smaltimento delle...
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