COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Augmentin» (19A00275)
Estratto determina IP n. 861 del 17 dicembre 2018 E' autorizzata l'importazione parallela del medicinale AUGMENTIN DUO 400 mg/5 ml + 57 mg/5 ml polvere per sospensione orale, flacone da 70 ml dalla Repubblica Ceca con numero di autorizzazione 15/265/00-C, intestato alla societa' Smithkline Beecham Limited e prodotto da Smithkline Beecham Pharmaceuticals (GB) e da Glaxo Wellcome Production (FR), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Programmi Sanitari Integrati S.r.l. con sede legale in via Giovanni Lanza, 3 20100 Milano (MI). Confezione: AUGMENTIN «bambini 400 mg/57 mg/5 ml polvere per sospensione orale» flacone 70 ml con siringa dosatrice. Codice A.I.C.: 038291112 (in base 10) - 14JKP8 (in base 32). Forma farmaceutica: polvere per sospensione orale. Composizione: ogni ml di sospensione contiene: principio attivo: amoxicillina triidrato corrispondente a 80 mg di amoxicillina e potassio clavulanato corrispondente a 11,4 mg di acido clavulanico;
eccipienti: magnesio stearato, aspartame (E951), crospovidone, gomma xantano, silice colloidale idrata, silice colloidale anidra, sodio benzoato, carmellosa sodica, aroma fragola (contenente maltodestrine). Officine di confezionamento secondario STM Group S.r.l. strada prov. Pianura, 2 - 80078 Pozzuoli (NA);
Prespack, Jacek Karonski Poland, Skorzewo, ul. Sadowa 38. 60-185;
Pharm@idea S.r.l. via del Commercio, 5 - 25039 Travagliato (BS). Classificazione ai fini della rimborsabilita' Confezione: «Augmentin» - bambini 400 mg/57 mg/5 ml polvere per sospensione orale - flacone 70 ml con siringa dosatrice. Codice A.I.C.: 038291112. Classe di rimborsabilita': «C(nn)». La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della...
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