COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Zolek». (15A05275)
Estratto determina n. 805/2015 del 19 giugno 2015 Medicinale: ZOLEK. Titolare A.I.C.: Neogen N.V. - Square Marie Curie, 50, edificio 5, 4° piano - 1070 Anderlecht - Belgio. Confezione: «4 mg/100 ml soluzione per infusione» 1 flaconcino in vetro da 100 ml - A.I.C. n. 043261015 (in base 10) 19872R (in base 32). Confezione: «4 mg/100 ml soluzione per infusione» 10 flaconcini in vetro da 100 ml - A.I.C. n. 043261027 (in base 10) 198733 (in base 32). Forma farmaceutica: soluzione per infusione. Composizione: un flaconcino contiene: principio attivo: 4 mg di acido zoledronico (come monoidrato). Eccipienti: mannitolo (E421);
sodio citrato;
acqua per preparazioni iniettabili;
azoto. Produzione del principio attivo: Pharmaceutical Works Polpharma SA - 19 Pelplinska Street, 83-200 Starogard Gdanski, Polonia. Natco Pharma Limited-Chemical Division - Mekaguda Village, Kothur Mandal, Mahaboob Nagar District, 500 223 Andra Pradesh, India. Produzione, confezionamento primario e secondario, controllo lotti: SM Farmacutici SRL - Zona industriale - 85050 Tito (PZ), Italia. Rilascio dei lotti: Neogen developments N.V. - Square Marie Curie 50, Anderlecht 1070, Belgio. SM Farmacutici SRL - Zona industriale - 85050 Tito (PZ), Italia. Indicazioni terapeutiche: prevenzione di eventi correlati all'apparato scheletrico (fratture patologiche, schiacciamenti vertebrali, radioterapia o interventi chirurgici all'osso, ipercalcemia neoplastica) in pazienti adulti affetti da tumori maligni allo stadio avanzato che interessano l'osso. trattamento di pazienti aduti con ipercalcemia neoplastica (TIH). Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano collocate, in virtu' dell'art. 12, comma 5, del Decreto Legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla Legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della...
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