COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio secondo procedura decentrata del medicinale per uso umano «Natemille» con conseguente modifica stampati. (18A04878)
Estratto determina AAM/PPA n. 611/2018 del 27 giugno 2018 L'autorizzazione all'immissione in commercio del Medicinale: NATEMILLE (041530) Confezioni: 041530015 - «600 mg + 1000 UI compresse orodispersibili» 60 compresse in flacone HDPE 041530027 - «600 mg + 1000 UI compresse orodispersibili" 30 compresse in flacone HDPE Titolare A.I.C.: Italfarmaco S.p.a. con sede legale e domicilio fiscale in viale Fulvio Testi, 330 - 20126 Milano, Italia - codice fiscale/partita IVA 00737420158 Procedura Decentrata Codice Procedura Europea: IT/H/0290/001/R/001 Codice pratica: FVRMR/2017/4 con scadenza il 22 ottobre 2017 e' rinnovata con validita' illimitata, con conseguente modifica del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e dell'Etichettatura, a condizione che, alla data di entrata in vigore della presente determina, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Le modifiche devono essere apportate per il Riassunto delle Caratteristiche del Prodotto dalla data di entrata in vigore della presente determina mentre per il Foglio Illustrativo ed Etichettatura entro e non oltre sei mesi dalla medesima data. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono...
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