COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Pafinur». (14A02334)
Estratto determinazione n. 222/2014 del 6 marzo 2014 Medicinale: PAFINUR Titolare AIC: BIOHORM, S.A. - Av. Cami' Reial, 51-57 - E-08184 Palau-solita' i Plegamans (Barcellona - Spagna) Confezione: "1 mg/ml soluzione orale" 1 flacone in PET da 120 ml con siringa graduata e chiusura a prova di bambino - AIC n. 037888094 (in base 10) 14482Y (in base 32) Forma farmaceutica: Soluzione orale Composizione: Ogni ml di soluzione orale contiene: Principio attivo: 1 mg di rupatadina (come fumarato) Eccipienti: Propilenglicole Acido citrico anidro Disodio fosfato anidro Saccarina sodica Saccarosio Metil paraidrossibenzoato (E218) Giallo chinolina (E104) Aroma di banana (Miscela di sostanze aromatizzanti, preparazioni aromatizzanti e sostanze aromatizzanti naturali, e propilenglicole) Produzione del principio attivo: Urquuima S.A., Arnau de Villanova 22-42, 08105 Sant Fost de Campsentelles, Spagna Produzione, confezionamento primario e secondario, controllo di qualita', rilascio dei lotti: Italfarmaco S.A., San Rafael, 3 Pol. Ind. Alcobendas, 28108 Alcobendas, Spagna Indicazioni terapeutiche: Pafinur 1 mg/ml soluzione orale e' indicato per il trattamento sintomatico della rinite allergica (inclusa la rinite allergica persistente) nei bambini di eta' compresa tra 6 e 11 anni. (classificazione ai fini della rimborsabilita') Confezione "1 mg/ml soluzione orale" 1 flacone in PET da 120 ml con siringa graduata e chiusura a prova di bambino - AIC n. 037888094 (in base 10) 14482Y (in base 32) Classe di rimborsabilita': A Nota...
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