COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Micofenolato Mofetile Actavis», con conseguente modifica stampati. (15A03284)
Estratto determina FV n. 111/2015 del 14 aprile 2015 Medicinale: MICOFENOLATO MOFETILE ACTAVIS. Confezioni: A.I.C. n. 038895 013 «500 mg compresse rivestite con film» 50 compresse in blister PVC/PVDC/AL;
A.I.C. n. 038895 025 «500 mg compresse rivestite con film» 100 compresse in blister PVC/PVDC/AL;
A.I.C. n. 038895 037 «500 mg compresse rivestite con film» 150 compresse in blister PVC/PVDC/AL. Titolare AIC: Actavis Group PTC EHF. Procedura: Decentrata SE/H/0709/001/R/001 Con scadenza il 18 dicembre 2013 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e dell'Etichettatura ed a condizione che, alla data di entrata in vigore della presente determinazione, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. E' approvata altresi' la variazione SE/H/0709/001/IB/011 - C1B/2012/2868, relativa all'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo. E' approvata altresi' la variazione SE/H/0709/001/IB/013 - C1B/2013/3146, relativa all'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo. E' approvata altresi' la variazione SE/H/0709/001/IB/015 - C1B/2014/2205, relativa all'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo. Le modifiche devono essere apportate immediatamente per il Riassunto delle Caratteristiche del Prodotto mentre per il Foglio Illustrativo ed Etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determinazione. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile...
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