COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Acido Zoledronico Injenerics» (16A07623)
Estratto determina n. 1363/2016 del 29 settembre 2016 Specialita' medicinale: ACIDO ZOLEDRONICO INJENERICS. Titolare A.I.C.: Injenerics S.r.l., piazza del Popolo n. 14, 22100 Como, Italia. Confezione: «4 mg/5 ml concentrato per soluzione per infusione» 1 flaconcino in vetro da 5 ml - A.I.C. n. 043746015 (in base 10) 19R0QZ (in base 32). Forma farmaceutica: concentrato per soluzione per infusione. Composizione: una fiala con 5 ml di concentrato contiene: Principio attivo: 4 mg di acido zoledronico, corrispondenti a 4,264 mg di acido zoledronico monoidrato. Eccipienti: Mannitolo Sodio citrato Acqua per preparazioni iniettabili Produzione principio attivo: Trifarma S.p.a., via delle Industrie n. 6, 20816 Ceriano Laghetto (MB), Italia Hangzhou Pharma &
Chem Co. Ltd. (Cina) (sintesi dell'intermedio acido imidazol acetico) Produzione: Sirton Pharmaceuticals S.p.A., piazza XX Settembre n. 2, 22079 Villa Guardia (CO). 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 adulti 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 rimborsabilita', della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, denominata classe C (nn). Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale ACIDO ZOLEDRONICO INJENERICS e' la seguente: medicinale soggetto a prescrizione medica limitativa, da rinnovare volta per volta, vendibile al pubblico su prescrizione di centri ospedalieri o di specialisti - internista, ortopedico...
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