COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Cisatracurio Kabi». (14A02327)
Estratto determinazione n. 207/2014 del 6 marzo 2014 Medicinale: CISATRACURIO KABI. Titolare AIC: Fresenius Kabi Italia S.r.l. Via Camagre, 41 37063 Isola della Scala Verona Confezione «5 mg/ml soluzione iniettabile o per infusione» 1 flaconcino in vetro da 30 ml AIC n. 039892132 (in base 10) 161F54 (in base 32) Confezione «5 mg/ml soluzione iniettabile o per infusione» 5 flaconcini in vetro da 30 ml AIC n. 039892144 (in base 10) 161F5J (in base 32) Forma farmaceutica: Soluzione iniettabile o per infusione (iniezione o infusione) Composizione: Principio attivo: 1 ml di soluzione iniettabile o per infusione contiene 6,7 mg di cisatracurio besilato equivalente a 5 mg di cisatracurio. 1 fiala da 30 ml di soluzione iniettabile o per infusione contiene 201 mg di cisatracurio besilato equivalente a 150 mg di cisatracurio. Eccipienti: Acido benzensolfonico 1% (per la regolazione del pH) Acqua per preparazioni iniettabili Produzione del principio attivo: Chemagis Ltd._Ramat Hovav P.O. Box 3593 84135 Beer Sheva Israele CF Pharma Ltd. Ken u. 5 H-1097 Budapest Ungheria Rilascio lotti: Fresenius Kabi Deutschland GmbH D-61346 Bad Homburg v.d.H (Head Office) Pfingstweide 53, 61169 Friedberg (Release Site) Germania Controllo lotti: SGS INSTITUT FRESENIUS GmbH Irn Maisel 14 65232 Taunusstein Germania LABESFAL Laboratorios Almiro S.A. (Fresenius Kabi Group) Zona Industrial do Lagedo, 3465 157 Santiago de Besteiros Portogallo Produzione e confezionamento primario e secondario: Fresenius Kabi Manufacturing SA (Pty) Ltd. 6 Gibaud Road, 6001 Korsten, Port Elizabeth Sud Africa Confezionamento secondario: Prestige Promotion GmbH Lindigstraße 6 63801 Kleinostheim Germania Indicazioni terapeutiche: Cisatracurio Kabi e' indicato per l'utilizzo durante le procedure chirurgiche e altre procedure e nella terapia intensiva negli adulti e bambini dall'eta' di un mese in su. Puo'...
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