COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Leponex» (14A02529)
Estratto determinazione n. 286/2014 del 17 marzo 2014 Medicinale: LEPONEX Titolare AIC: Novartis Farma S.p.A. Largo Umberto Boccioni, 1 - 21040 Origgio (VA) Confezione "25 mg compresse" 28 compresse in blister PVC/PE/PVDC/AL AIC n. 028824035 (in base 10) 0VHNH3 (in base 32) Confezione "100 mg compresse" 28 compresse in blister PVC/PE/PVDC/AL AIC n. 028824047 (in base 10) 0VHNHH (in base 32) Forma farmaceutica: Compressa. Composizione: Ogni compressa contiene: Principio attivo: 25 mg, 100 mg di clozapina. Classificazione ai fini della rimborsabilita' Confezione "25 mg compresse" 28 compresse in blister PVC/PE/PVDC/AL AIC n. 028824035 (in base 10) 0VHNH3 (in base 32) Classe di rimborsabilita': A Prezzo ex factory (IVA esclusa): €
6,06 Prezzo al pubblico (IVA inclusa): €
10,00 Confezione "100 mg compresse" 28 compresse in blister PVC/PE/PVDC/AL AIC n. 028824047 (in base 10) 0VHNHH (in base 32) Classe di rimborsabilita': A Prezzo ex factory (IVA esclusa): €
20,00 Prezzo al pubblico (IVA inclusa): €
33,00 Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale LEPONEX e' la seguente: Da vendersi dietro presentazione di ricetta medica utilizzabile una sola volta, attestante l'esecuzione (settimanale per le prime 18 settimane e mensile successivamente) della conta e della formula leucocitaria e la compatibilita' dei valori riscontrati con l'inizio, la prosecuzione o la ripresa del trattamento. Prescrizione riservata esclusivamente ai centri ospedalieri e ai dipartimenti di salute mentale, da parte di specialisti in psichiatria o in neuropsichiatria (RNRL). Condizioni e modalita' di impiego Prescrizione del medicinale soggetta a diagnosi - piano terapeutico e a quanto previsto dall'allegato 2 e successive modifiche, alla determinazione 29 ottobre 2004 - PHT Prontuario della distribuzione diretta -, pubblicata nel supplemento ordinario alla Gazzetta Ufficiale n. 259 del 4 novembre 2004. Autorizzazione modifiche stampati e altre variazioni chimiche Relativamente alle confezioni del medicinale gia' autorizzate (codici AIC n. 028824011, AIC n. 028824023) nonche' alle confezioni autorizzate dalla presente determina: E' autorizzata la modifica degli stampati sezione 4.8 in linea con il...
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