COMUNICATO - Comunicato di annullamento del provvedimento di variazione di tipo «IA/IB», relativo al medicinale «Vancomicina Hikma». (Codice pratica n. N1A/2011/2569). (12A09502)
Medicinale: VANCOMICINA HIKMA (A.I.C.: 035004).
Codice confezioni: 035004023 (Autorizzata), 035004035 (Autorizzata), 035004011 (Autorizzata).
Il provvedimento di Variazione di tipo «IA/IB» relativo alla Specialita' medicinale per uso umano VANCOMICINA HIKMA (A.I.C.: 035004). Titolare Hikma Italia S.p.A., codici confezione: 035004023 (Autorizzata), 035004035 (Autorizzata), 035004011 (Autorizzata), quale modifica apportata ai sensi dell'art. 35, comma 1-bis, del decreto legislativo 24 aprile 2006 n. 219 e ss.mm.ii., pubblicata, secondo i termini previsti dall' art. 2 della determina AIFA del 18 dicembre 2009, e ss.mm.ii., dalla Ditta Hikma Italia S.p.A. in data 24 marzo 2012 nella Gazzetta Ufficiale Parte II n. 36 e' annullato d'ufficio ad ogni effetto di legge.
L'annullamento viene disposto, ai sensi dell'art. 21-nonies della legge n. 241/1990, in quanto a seguito di approfondimento e' stato verificato che la pubblicazione nella Gazzetta Ufficiale da parte della Ditta e' stata effettuata senza attendere il parere finale da parte di AIFA, quando cioe' i termini del silenzio-assenso erano stati interrotti dalla richiesta integrazione del 20 gennaio 2012. L'annullamento viene inoltre disposto, in quanto a seguito di approfondimento e' stata comunicata alla Ditta con lettera dell'8 giugno 2012, prot. AIFA/V & A/P/56348, la notifica non regolare per la pratica in...
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