COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Cefixima Eurogenerici» (13A06200)
Estratto determinazione n. 622/2013 del 9 luglio 2013 Medicinale: CEFIXIMA EUROGENERICI Titolare AIC: EG S.p.A., Via D. Scarlatti, 31 - 20124 Milano Confezione «400 mg compresse dispersibili» 5 compresse in blister PVC/ACLAR/AL AIC n. 042087015 (in base 10) 184DM7 (in base 32) Confezione «400 mg compresse dispersibili» 5 compresse in blister PVC/PVDC/AL AIC n. 042087027 (in base 10) 184DMM (in base 32) Forma farmaceutica: Compressa dispersibile Composizione: Ogni compressa dispersibile contiene: Principio attivo: 447,63 mg di cefixima triidrata, equivalente a 400 mg di cefixima (anidra) Eccipienti: Cellulosa microcristallina Croscarmellosa sodica Saccarina calcica Povidone K 30 Silice colloidale anidra Magnesio stearato Aroma fragola Colorante giallo Tramonto (E110) Produttore del principio attivo: Orchid Chemicals &
Pharmaceuticals Limited Plot n. 138-149, SIDCO Industrial Estate, Alathur, Kancheepuram District - 603110 Tamil Nadu, INDIA Produzione, confezionamento primario: Hospira Healthcare India Pvt. Ltd. Plot Nos.: B3-B4, B5 (pt), B6 (pt), B11-B18, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram - 602 105, Tamil Nadu, INDIA Rilascio e controllo dei lotti: DOPPEL Farmaceutici Srl Via Volturno, 48 20089 Quinto de' Stampi Rozzano (MI) Italia Confezionamento secondario: DE SALUTE Srl Via Biasini, 26 26015 Soresina (CR) Italia Indicazioni terapeutiche: Cefixima e' indicato nel trattamento delle seguenti infezioni sostenute da microorganismi sensibili: Riacutizzazioni della bronchite cronica Polmonite acquisita in comunita' Infezioni non complicate della basse vie urinarie Pielonefrite non complicata. Nel trattamento di: Otite media Sinusite Faringite. L'uso di Cefixima deve essere riservato alle infezioni di cui e' noto o si sospetta che il microrganismo responsabile sia resistente ad altri agenti antibatterici comuni o quando l'insuccesso del trattamento possa causare un rischio significativo. Si...
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