COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Eptifibatide Strides Arcolab International». (14A02329)
Estratto determinazione n. 211/2014 del 6 marzo 2014 Medicinale: EPTIFIBATIDE STRIDES ARCOLAB INTERNATIONAL. Titolare AIC: Strides Arcolab International Ltd. Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD 18 9SS, Regno Unito. Confezione «0,75 mg/ml soluzione per infusione» 1 flaconcino in vetro da 100 ml AIC n. 042033011(in base 10) 182RVM (in base 32) Confezione «2 mg/ml soluzione per infusione» 1 flaconcino in vetro da 10 ml AIC n. 042033023(in base 10) 182RVZ (in base 32) Forma farmaceutica: Soluzione iniettabile Composizione: Ogni ml di soluzione iniettabile contiene: Principio attivo: 0,75 mg, 2 mg di eptifibatide Eccipienti: Acido citrico monoidrato Idrossido di sodio (per regolare il pH) Acqua per soluzioni iniettabili. Produzione: Agila Specialities Private Limited, Speciality Formulation Facility, 19A, Plot N.284, B/1, Bommasandra-Jigani Link Road, Industrial Area, Jigani Hobli, Anekal Taluk, Bangalore, India Confezionamento: Agila Specialities Private Limited, Speciality Formulation Facility, 19A,Plot N.284, B/1, Bommasandra-Jigani Link Road, Industrial Area, Jigani Hobli, Anekal Taluk, Bangalore, India Produzione principio attivo: Plantex Ltd., 1 HaKadar St., Industrial Zone, Netanya 42101, Israele Rilascio lotti: Agila Specialties Polska Sp. Z. o. o., 10, Daniszewska Str., 03-230 Warsaw, Polonia Controllo dei lotti: Agila Specialties Polska Sp. Z. o. o., 10, Daniszewska Str., 03-230 Warsaw, Polonia Indicazioni terapeutiche: Eptifibatide deve essere utilizzato con acido acetilsalicilico ed eparina non frazionata. Eptifibatide e' indicato per la prevenzione di infarti del miocardio in fase iniziale in soggetti adulti affetti da angina instabile o infarto del miocardio senza onda Q che abbiano avuto l'ultimo episodio di dolore toracico nelle ultime 24 ore, e che presentino modifiche dell'elettrocardiogramma (ECG) e/o valori...
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