COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Nurofen febbre e dolore» (18A06875)
Estratto determina IP n. 629 del 18 settembre 2018 (descrizione del medicinale da importare e attribuzione del numero di identificazione) E' autorizzata l'importazione parallela del NUROFEN FOR CHILDREN, oral suspension 100 mg/5 ml dalla Grecia con numero di autorizzazione 46452/13.10.2008, intestato alla societa' Reckitt Benckiser Hellas Chemicals Sa e prodotto da Almirall Hermal Gmbh, Reinbek, Germany e da Reckitt Benckiser Healthcare (UK) Limited, U.K., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Gekofar S.r.l. con sede legale in piazza Duomo, 16 - 20122 Milano. Confezione: NUROFEN FEBBRE E DOLORE «bambini 100 mg/5 ml sospensione orale gusto arancia senza zucchero» flacone da 150 ml con siringa dosatrice;
Codice A.I.C.: 042094021 (in base 10) 184MG5 (in base 32). Forma farmaceutica: sospensione orale;
Composizione: ogni ml di sospensione orale contiene: Principio attivo: Ibuprofene 20 mg. Eccipienti: Polisorbato 80, glicerina, sciroppo di maltitolo, saccarina sodica, acido citrico, sodio citrato, gomma di xanthan, sodio cloruro, aroma arancia, bromuro di domifene, acqua depurata. Indicazioni terapeutiche: trattamento sintomatico della febbre e del dolore lieve o moderato. Come conservare «Nurofen Febbre e Dolore»: temperatura di conservazione inferiore ai 25°. Officine di confezionamento secondario: S.C.F. S.r.l. via F. Barbarossa, 7 - 26824 Cavenago D'adda - LO;
Cit S.r.l. via Primo Villa n. 17 - 20875 Burago di Molgora (MB);
Pb Beltracchini S.r.l. via S Erasmo, 6 - 20027...
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