COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale per uso umano «Dralenos», con conseguente modifica stampati. (14A02873)
Estratto determinazione FV n. 82/2014 del 18 marzo 2014 Medicinale: DRALENOS. Rinnovo dell'autorizzazione all'immissione in commercio secondo procedura di mutuo riconoscimento NL/H/0818/001-002/R/002 del medicinale DRALENOS, con conseguente modifica stampati. Confezioni: 038031 011 «10 mg compresse» 10 compresse in blister PVC/AL;
038031 023 «10 mg compresse» 14 compresse in blister PVC/AL;
038031 035 «10 mg compresse» 28 compresse in blister PVC/AL;
038031 047 «10 mg compresse» 30 compresse in blister PVC/AL;
038031 050 «10 mg compresse» 98 compresse in blister PVC/AL;
038031 062 «10 mg compresse» 28 compresse in contenitore PP;
038031 074 «10 mg compresse» 30 compresse in contenitore PP;
038031 086 «10 mg compresse» 50 compresse in contenitore PP;
038031 098 «10 mg compresse» 56 compresse in contenitore PP;
038031 100 «10 mg compresse» 98 compresse in contenitore PP;
038031 112 «10 mg compresse» 100 compresse in contenitore PP;
038031 124 «10 mg compresse» 112 compresse in contenitore PP;
038031 136 «10 mg compresse» 250 compresse in contenitore PP;
038031 148 «70 mg compresse» 4 compresse in blister PVC/AL;
038031 151 «70 mg compresse» 8 compresse in blister PVC/AL;
038031 163 «70 mg compresse» 12 compresse in blister PVC/AL;
038031 175 «70 mg compresse» 4 compresse in contenitore PP;
038031 187 «70 mg compresse» 8 compresse in contenitore PP;
038031 199 «70 mg compresse» 12 compresse in contenitore PP. Titolare A.I.C.: Istituto Biochimico Nazionale Savio S.r.l. Procedura mutuo riconoscimento NL/H/0818/001-002/R/002 , con scadenza il 30 settembre 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...
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