COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale per uso umano «Mirtazapina doc generici», con conseguente modifica stampati. (15A00586)
Estratto determina FV n. 10/2015 del 13 gennaio 2015 Medicinale: MIRTAZAPINA DOC GENERICI Confezioni: 038701 013 "15 mg compresse orodispersibili" 6 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 025 "15 mg compresse orodispersibili" 18 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 037 "15 mg compresse orodispersibili" 30 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 049 "15 mg compresse orodispersibili" 48 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 052 "15 mg compresse orodispersibili" 90 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 064 "15 mg compresse orodispersibili" 96 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 076 "30 mg compresse orodispersibili" 6 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 088 "30 mg compresse orodispersibili" 18 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 090 "30 mg compresse orodispersibili" 30 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 102 "30 mg compresse orodispersibili" 48 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 114 "30 mg compresse orodispersibili" 90 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 126 "30 mg compresse orodispersibili" 96 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 138 "45 mg compresse orodispersibili" 6 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 140 "45 mg compresse orodispersibili" 18 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 153 "45 mg compresse orodispersibili" 30 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 165 "45 mg compresse orodispersibili" 48 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 177 "45 mg compresse orodispersibili" 90 compresse PA/AL/PVC/CARTA/POLIESTERE/AL 038701 189 "45 mg compresse orodispersibili" 96 compresse PA/AL/PVC/CARTA/POLIESTERE/AL Titolare AIC: DOC GENERICI S.R.L. Procedura Mutuo Riconoscimento NL/H/1261/001-003/R/001 con scadenza il 26 febbraio 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...
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