COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Brufen» (15A05117)
Estratto determina n. 1147 del 12 giugno 2015 E' autorizzata l'importazione parallela del medicinale NEOBRUFEN 600 mg comprimidos recubiertos con pelicula 40 comprim. dalla Spagna con numero di autorizzazione 70031 Codigo Nacional 661407-5, il quale, per le motivazioni espresse in premessa, deve essere posto in commercio con la denominazione BRUFEN e con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: New Pharmashop S.r.l. Cis di Nola Isola 1 - Torre 1 - Int. 120 - 80035 Nola. Confezione: «Brufen 600 mg compresse rivestite» 30 compresse in blister - Codice A.I.C.: 043890019 (in base 10) 19VFC3 (in base 32). Forma farmaceutica: compresse rivestite. Composizione: ogni compressa rivestita contiene: principio attivo: ibuprofene 600 mg;
eccipienti: cellulosa microcristallina, lattosio monoidrato, croscarmellosa sodica, sodio laurilsolfato, magnesio stearato, silice colloidale anidra, ipromellosa, talco, ipromellosa E-5, titanio diossido E-171. Indicazioni terapeutiche Come antireumatico in: osteoartrosi in tutte le sue localizzazioni (artrosi cervicale, dorsale, lombare;
artrosi della spalla, dell'anca, del ginocchio, artrosi diffusa, ecc.), periartrite scapolo-omerale, lombalgie, sciatalgie, radicolo-nevriti;
fibrositi, tenosinoviti, miositi, traumatologia sportiva;
artrite reumatoide, morbo di Still. Come analgesico in forme dolorose di diversa eziologia: nella traumatologia accidentale e sportiva;
nella pratica dentistica, nei dolori post-estrazione e dopo interventi odontostomatologici;
in ostetricia: nel dolore post-episiotomico e post-partum;
in ginecologia: nella prevenzione e nel trattamento della dismenorrea;
in chirurgia: nel trattamento del dolore post-operatorio;
in oculistica: nel dolore post-operatorio e...
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