COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Gliclazide Teva Italia», con conseguente modifica stampati. (15A06133)
Estratto determina FV n. 180/2015 del 13 luglio 2015 Medicinale: GLICLAZIDE TEVA ITALIA. Confezioni: 038372 013 «30 mg compresse a rilascio modificato» 10 compresse in blister PVC/AL 038372 025 «30 mg compresse a rilascio modificato» 14 compresse in blister PVC/AL 038372 037 «30 mg compresse a rilascio modificato» 20 compresse in blister PVC/AL 038372 049 «30 mg compresse a rilascio modificato» 28 compresse in blister PVC/AL 038372 052 «30 mg compresse a rilascio modificato» 30 compresse in blister PVC/AL 038372 064 «30 mg compresse a rilascio modificato» 56 compresse in blister PVC/AL 038372 076 «30 mg compresse a rilascio modificato» 60 compresse in blister PVC/AL 038372 088 «30 mg compresse a rilascio modificato» 84 compresse in blister PVC/AL 038372 090 «30 mg compresse a rilascio modificato» 90 compresse in blister PVC/AL 038372 102 «30 mg compresse a rilascio modificato» 100 compresse in blister PVC/AL 038372 114 «30 mg compresse a rilascio modificato» 120 compresse in blister PVC/AL 038372 126 «30 mg compresse a rilascio modificato» 180 compresse in blister PVC/AL 038372 138 «30 mg compresse a rilascio modificato» 90 compresse in contenitore HDPE 038372 140 «30 mg compresse a rilascio modificato» 120 compresse in contenitore HDPE 038372 153 «30 mg compresse a rilascio modificato» 180 compresse in contenitore HDPE Titolare AIC: TEVA Italia S.r.l. Procedura decentrata DE/H/0895/001/R/001. Con scadenza il 30 novembre 2011 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...
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