COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Cisplatino Accord Healthcare Italia». (13A03827)
Estratto determinazione n. 409/2013 del 16 aprile 2013 MEDICINALE CISPLATINO ACCORD HEALTHCARE ITALIA TITOLARE AIC: Accord Healthcare Italia S.r.l. Largo Esterle, 4 20052 Monza (MB) Italia Confezione "1 mg/ml concentrato per soluzione per infusione" 1 flaconcino in vetro da 100 ml AIC n. 040210041/M (in base 10) 16C3MT (in base 32) FORMA FARMACEUTICA: Concentrato per soluzione per infusione. COMPOSIZIONE: 1 ml di concentrato per soluzione per infusione contiene: Principio attivo: 1 mg di cisplatino. 10 ml di concentrato per soluzione per infusione contengono 10 mg di cisplatino. 25 ml di concentrato per soluzione per infusione contengono 25 mg di cisplatino. 50 ml di concentrato per soluzione per infusione contengono 50 mg di cisplatino. 100 ml di concentrato per soluzione per infusione contengono 100 mg di cisplatino. Eccipienti: Sodio cloruro Sodio idrossido (per aggiustare il pH) Acido cloridrico (per aggiustare il pH) Acqua per preparazioni iniettabili Produzione, confezionamento e controllo: Intas Pharmaceuticals Limited Plot No. 457 - 458, Sarkhej-Bavla Highway, Matoda, Tal. Sanand Ahmedabad-382210 India Intas Pharma Limited. Plot n. 5, 6 and 7, Pharmez, Nr. Village Matoda, Taluka-Sanand Dist. Ahmedabad-382 210, Gujarat India Controllo lotti: Astron Research Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, Regno Unito Rilascio lotti: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, Regno Unito Confezionamento secondario: Accord Healthcare Limited Unit C, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP Regno Unito Produzione Principio Attivo: Sun Pharmaceuticals Limited A-7/A-8, M.I.D.C. Industrial Area, Ahmednagar, 414111, Maharashtra India HERAEUS PRECIOUS METALS GMBH &
CO.KG Heraeusstrasse 12-14, Germany-63450 Germania INDICAZIONI TERAPEUTICHE: Il...
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