PROVVEDIMENTO 13 febbraio 1998 - Proroga del provvedimento CUF 17 gennaio 1997 inerente l'inserimento del medicinale "Deferiprone" nell'elenco dei medicinali erogabili a totale carico del Servizio sanitario nazionale
PROVVEDIMENTO 13 febbraio 1998.
Proroga del provvedimento CUF 17 gennaio 1997 inerente l'inserimento del medicinale "Deferiprone" nell'elenco dei medicinali erogabili a totale carico del Servizio sanitario nazionale.
LA COMMISSIONE UNICA DEL FARMACO
Vista la legge 23 dicembre 1996, n. 648, di conversione del decreto-legge 21 ottobre 1996, n. 536, relativo alle misure per il contenimento della spesa farmaceutica e la determinazione del tetto di spesa per l'anno 1996, pubblicata nella Gazzetta Ufficiale n. 300 del 23 dicembre 1996; Visto il decreto legislativo 29 maggio 1991, n, 178, concernente il recepimento delle direttive della Comunita' economica europea in materia di specialita' medicinali, pubblicato nella Gazzetta Ufficiale n. 139, del 15 giugno 1991; Visto il decreto legislativo 18 febbraio 1997, n. 44, di attuazione della direttiva 93/39/CEE, che modifica le direttive 65/65/CEE e 75/319/CEE relative ai medicinali, pubblicato nella Gazzetta Ufficiale n. 54 del 6 marzo 1997; Visto il proprio provvedimento in data 17 gennaio 1997, con il quale, ai sensi dell'art. 1, comma 4, del decreto-legge 21 ottobre 1996, n. 536, convertito dalla legge 23 dicembre 1996, n. 648, e' stato istituito l'elenco dei medicinali innovativi la cui commercializzazione e' autorizzata in altri Stati ma non sul territorio nazionale, dei medicinali non ancora autorizzati ma sottoposti a sperimentazione clinica e dei medicinali da impiegare per un'indicazione terapeutica diversa da quella autorizzata, da erogarsi a totale carico ed a cura del Servizio sanitario nazionale a soggetti che per la loro patologia non dispongono di valida alternativa terapeutica, pubblicato nella Gazzetta Ufficiale n. 24 del 30 gennaio 1997; Considerato che l'art. 3 del richiamato...
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