COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale per uso umano «Nebivololo Teva», con conseguente modifica stampati. (16A03191)
Estratto determina FV N. 70/2016 del 6 aprile 2016 Medicinale: NEBIVOLOLO TEVA Confezioni: 038022 012 "5 mg compresse" 7 compresse in blister PVC/PE/PVDC/AL 038022 024 "5 mg compresse" 10 compresse in blister PVC/PE/PVDC/AL 038022 036 "5 mg compresse" 14 compresse in blister PVC/PE/PVDC/AL 038022 048 "5 mg compresse" 20 compresse in blister PVC/PE/PVDC/AL 038022 051 "5 mg compresse" 28 compresse in blister PVC/PE/PVDC/AL 038022 063 "5 mg compresse" 30 compresse in blister PVC/PE/PVDC/AL 038022 075 "5 mg compresse" 50 compresse in blister PVC/PE/PVDC/AL 038022 087 "5 mg compresse" 56 compresse in blister PVC/PE/PVDC/AL 038022 099 "5 mg compresse" 60 compresse in blister PVC/PE/PVDC/AL 038022 101 "5 mg compresse" 90 compresse in blister PVC/PE/PVDC/AL 038022 113 "5 mg compresse" 100 compresse in blister PVC/PE/PVDC/AL 038022 125 "5 mg compresse" 120 compresse in blister PVC/PE/PVDC/AL Titolare AIC: Teva Italia S.R.L. Procedura Mutuo Riconoscimento DK/H/1012/001/R/001 con scadenza il 20 marzo 2012 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica 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 per l'etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente...
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