COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Singulair». (15A05110)
Estratto determina n. 1138 del 12 giugno 2015 E' autorizzata l'importazione parallela del medicinale SINGULAIR 10, 10 mg tabletki pow. 28 tabs. dalla POLONIA con numero di autorizzazione 7957 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione. Importatore: Farma 1000 S.r.l., via Camperio Manfredo n. 9, 20123 Milano;
Confezione: SINGULAIR «10 mg compresse rivestite con film» 28 compresse. Codice A.I.C.: 043949015 (in base 10) 19X6YR (in base 32). Forma farmaceutica: compresse rivestite. Una compressa rivestita con film contiene: Principio attivo: Montelukast sodico, equivalente a 10 mg di Montelukast. Eccipienti: Lattosio monoidrato. Cellulosa microcristallina, Croscarmellosa sodica, Iprolosa (E 463), Magnesio stearato. Rivestimento: Ipromellosa, Iprolosa (E 463), Titanio diossido (E 171), Ferro ossido rosso e giallo (E 172), Cera carnauba. Indicazioni terapeutiche: SINGULAIR e' indicato per il trattamento dell'asma come terapia aggiuntiva in quei pazienti con asma persistente di lieve/moderata entita' che non sono adeguatamente controllati con corticosteroidi per via inalatoria e nei quali gli agonisti β-adrenergici a breve durata d'azione assunti «al bisogno» forniscono un controllo clinico inadeguato dell'asma. SINGULAIR puo' essere utilizzato anche per il trattamento sintomatico della rinite allergica stagionale nei pazienti in cui SINGULAIR e' indicato per l'asma. SINGULAIR e' anche indicato per la profilassi dell'asma laddove la componente predominante e' la broncocostrizione indotta...
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