COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Nurofen influenza e raffreddore» (19A03991)
Estratto determina IP n. 382 del 22 maggio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale NUROFEN COLD&FLU FILM COATED TABLET (200+30) mg/tab 24 tab dalla Grecia con numero di autorizzazione 17168/14-5-09, intestato alla societa' Reckitt Benckiser Hellas Chemicals (SA) e prodotto da Reckitt Benckiser Healthcare International LTD (Nottinghamshire UK), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Pricetag S.p.a. con sede legale in via Vasil Levski n. 103 - 1000 Sofia. Confezione: NUROFEN INFLUENZA E RAFFREDDORE «200 mg + 30 mg compresse rivestite» 12 compresse rivestite. Codice A.I.C. n.: 047406018 (in base 10) 1F6QY2 (in base 32). Forma farmaceutica: compressa rivestita. Composizione: una compressa rivestita contiene: principio attivo: ibuprofene 200 mg, pseudoefedrina cloridrato 30 mg;
eccipienti: fosfato tricalcico, croscarmellosa sodica (vedere paragrafo «Nurofen influenza e raffreddore contiene»), cellulosa microcristallina, polividone, magnesio stearato;
rivestimento: metilidrossipropilcellulosa, talco, giallo di chinolina (E104), giallo tramonto FCF (E110) (vedere paragrafo «Nurofen influenza e raffreddore contiene»), biossido di titanio (E171), alcool etilico denaturato, inchiostro nero di stampa (gomma lacca 45%, ferro ossido nero E172, propilenglicole, alcol isopropilico, alcol butilico, etanolo, acqua purificata). Come conservare «Nurofen influenza e raffreddore»: temperatura di conservazione inferiore a 25°C. Officine di confezionamento secondario: S.C.F. s.r.l. via F. Barbarossa n. 7 - 26824 Cavenago D'Adda - LO;
Pricetag Ead Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria);
Falorni s.r.l. via Provinciale Lucchese, localita' Masotti 51030...
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