COMUNICATO - Autorizzazione all''importazione parallela del medicinale «Nasonex Nasal Spray Suspension 50 mcg/dose»
Estratto determinazione AIP/UPC n. 172 del 20 novembre 2008
E' autorizzata l'importazione parallela del medicinale NASONEX Nasal Spray suspension 50 mcg/dose dalla Grecia con numero di autorizzazione 49981/12-10-2007, alle condizioni e con le specificazioni di seguito indicate
Importatore: Pharmazena S.r.l., con sede legale e domicilio fiscale in piazza della Vittoria n. 8/20 - Genova.
Denominazione e confezione: Nasonex Spray Nasale 0,05% 140 erog. 50 mcg/spruzzo
Codice IP: 038680017 (in base 10), 14WFGK (in base 32).
Forma farmaceutica: spray nasale, sospensione.
Composizione : ogni erogazione dosata contiene:
principio attivo: Mometasone Furoato monoidrato 50 mcg;
eccipienti: cellulosa dispersibile, glicerolo, sodio citrato diidrato, acido citrico monoidrato, polisorbato 80, benzalconio cloruro, alcool feniletilico, acqua depurata.
Indicazioni terapeutiche: Nasonex spray nasale e' indicato nel trattamento dei sintomi della rinite allergica stagionale o perenne negli adulti e nei ragazzi di almeno dodici anni di eta'.
Nasonex spray nasale e' indicato anche nel trattamento dei sintomi della rinite allergica stagionale o perenne nei bambini di eta' compresa tra sei e undici anni.
In pazienti con anamnesi positiva per sintomi di rinite allergica stagionale di entita' da moderata a grave, il trattamento profilattico con Nasonex spray nasale puo' essere iniziato fino a quattro settimane prima dell'inizio previsto della stagione dei pollini.
Nasonex spray nasale e' indicato per il trattamento dei polipi nasali in pazienti adulti a partire dai 18 anni di eta'.
Riconfezionamento secondario:
e' autorizzato...
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