COMUNICATO - Rettifica degli stampati relativi al medicinale «Mifegyne®» (11A03172)
Estratto determinazione n. 2084 / 2011 del 23 febbraio 2011
E' rettificata la Sezione 2 del foglio illustrativo del medicinale MIFEGYNE® , autorizzato all'immissione in commercio con la determinazione n. 1460/2009 del 23 novembre 2009, il cui estratto e' stato pubblicato nella Gazzetta Ufficiale n. 286 del 9 dicembre 2009 - supplemento ordinario n. 229 - Titolare AIC: Exelgyn, 216 Boulevard Saint-Germain, 75007 Parigi (Francia), nei punti seguenti:
PRIMA DI PRENDERE MIFEGYNE
[...]
Per l'interruzione della gravidanza oltre il 3° mese di gestazione:
se sono state utilizzate prostaglandine per completare l'azione di Myfegine, faccia riferimento alle controindicazioni presenti nel foglio illustrativo di quella prostaglandina.
Per l'induzione del travaglio in caso di morte fetale in utero:
a causa della necessita' di prescrivere una prostaglandina in associazione con Mifegyne, non deve assumere questo trattamento se e' allergica alle...
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