COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale per uso umano «Venlafaxina Eurogenerici», con conseguente modifica stampati. (15A02331)
Estratto determina FV n. 59/2015 del 26 febbraio 2015 Medicinale: VENLAFAXINA EUROGENERICI. Confezioni: 03884 019 «37,5 mg compresse» 7 compresse in ACLAR/PVC/AL 03884 021 «37,5 mg compresse» 10 compresse in ACLAR/PVC/AL 03884 033 «37,5 mg compresse» 14 compresse in ACLAR/PVC/AL 03884 045 «37,5 mg compresse» 15 compresse in ACLAR/PVC/AL 03884 058 «37,5 mg compresse» 20 compresse in ACLAR/PVC/AL 03884 060 «37,5 mg compresse» 28 compresse in ACLAR/PVC/AL 03884 072 «37,5 mg compresse» 30 compresse in ACLAR/PVC/AL 03884 084 «37,5 mg compresse» 50 compresse in ACLAR/PVC/AL 03884 096 «37,5 mg compresse» 56 compresse in ACLAR/PVC/AL 03884 108 «37,5 mg compresse» 60 compresse in ACLAR/PVC/AL 03884 110 «37,5 mg compresse» 84 compresse in ACLAR/PVC/AL 03884 122 «37,5 mg compresse» 90 compresse in ACLAR/PVC/AL 03884 134 «37,5 mg compresse» 98 compresse in ACLAR/PVC/AL 03884 146 «37,5 mg compresse» 100 compresse in ACLAR/PVC/AL 03884 159 «37,5 mg compresse» 112 compresse in ACLAR/PVC/AL 03884 161 «37,5 mg compresse» 120 compresse in ACLAR/PVC/AL 03884 173 «37,5 mg compresse» 150 compresse in ACLAR/PVC/AL 03884 185 «37,5 mg compresse» 200 compresse in ACLAR/PVC/AL Titolare AIC: EG S.P.A. Procedura Mutuo Riconoscimento DE/H/1489/001/R/001. Con scadenza il 06/11/2012 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. 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...
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