COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Brufen» (18A01967)
Estratto determina CIP IP N.167 del 28 febbraio 2018 E' autorizzata l'importazione parallela del medicinale NEOBRUFEN 600 mg comprimidos recubiertos con pelicula 40 comprimidos dalla Spagna con numero di autorizzazione 70031 Codigo Nacional 661407-5 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Pricetag S.p.a. con sede legale in Vasil Levski St. 103 - 1000 Sofia;
Confezione: BRUFEN «600 mg compresse rivestite» 30 compresse in blister. Codice A.I.C.: 045698014 (in base 10) 1CLLYY (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 nelle forme dolorose di varia eziologia;
in medicina generale: nel trattamento...
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