COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Brufen» (18A00832)
Estratto determina IP n. 5 dell'8 gennaio 2018 E' autorizzata l'importazione parallela del medicinale NEOBRUFEN 600 mg granulado effervescente 40 sobres (Sobre de Aluminio/Polietileno) dalla Spagna con numero di autorizzazione 61610 Codigo Nacional 669960-7 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: GMM Farma s.r.l. con sede operativa presso Cis di Nola - Isola 8, Lotto 8100, 80035 Nola (Napoli) e sede amministrativa presso via Lambretta 2, 20090 Segrate (MI). Confezione: BRUFEN «600 mg granulato effervescente» 30 bustine. Codice AIC: 042859025 (in base 10) 18VYJK (in base 32). Forma farmaceutica: granulato effervescente. Composizione: una bustina di granulato da 600 mg contiene: principio attivo: ibuprofene 600 mg;
eccipienti: acido malico, aroma arancia, cellulosa microcristallina, croscarmellosio sodico, povidone, saccarosio, sodio bicarbonato, sodio carbonato anidro, sodio laurilsolfato, sodio saccarinato, alcool isopropilico. 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...
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