COMUNICATO - Rettifica all'estratto della determinazione V & A.N/ n. 1606/2012 del 19 ottobre 2012, relativa all'autorizzazione all'immissione in commercio del medicinale per uso umano «Combitimor». (13A10536)
Estratto determinazione V &
A/2232 del 17 dicembre 2013 Medicinale: COMBITIMOR. Titolare A.I.C.: Sooft Italia S.p.A. con sede legale e domicilio fiscale in Contrada Molino, 17 - 63833 Montegiorgio (Fermo), codice fiscale 01624020440. Variazione A.I.C.: Richiesta rettifica determinazione. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato, alla determinazione V &
A.N/ n. 1606/2012 del 19 ottobre 2012 e relativo estratto pubblicato nella Gazzetta Ufficiale della Repubblica italiana - serie generale - n. 259 del 6 novembre 2012, concernente «l'Autorizzazione all'immissione in commercio» del medicinale "COMBITIMOR" e' apportata la seguente modifica: all'art. 1 (descrizione del medicinale e attribuzione Numero A.I.C.) al paragrafo Indicazioni terapeutiche invece di: Indicazioni terapeutiche: collirio soluzione: trattamento delle infiammazioni oculari quando e' necessario un corticosteroide e quando esista un'infezione oculare o il rischio di infezioni oculari negli adulti e nei bambini dai due anni di eta' in poi;
gocce auricolari soluzione: trattamento delle infiammazioni del condotto uditivo esterno e dell'orecchio medio quando si ritenga necessario l'impiego di un corticosteroide, in presenza di infezione causata da batteri sensibili alla tobramicina o quando esista il rischio di un'infezione;
leggasi: Indicazioni terapeutiche: collirio soluzione...
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