PROVVEDIMENTO 23 marzo 1998 - Riclassificazione della specialita' medicinale "Dicloreum"
LA COMMISSIONE UNICA DEL FARMACO
Visto il decreto legislativo 30 giugno 1993, n. 266, concernente: "Riordinamento del Ministero della sanita', a norma dell'art. 1, comma 1, lettera h), della legge 23 ottobre 1992, n. 421", con particolare riferimento all'art. 7, che istituisce la Commissione unica del farmaco; Visto il proprio provvedimento 30 dicembre 1993, pubblicato nel supplemento ordinario n. 127 alla Gazzetta Ufficiale n. 306 del 31 del dicembre 1993, con cui si e' proceduto alla riclassificazione dei medicinali, ai sensi dell'art. 8, comma 10, della legge 24 dicembre 1993, n. 537, e successive modifiche ed integrazioni; Visto il decreto del Ministro della sanita' 10 dicembre 1996, pubblicato nel supplemento ordinario n. 22 alla Gazzetta Ufficiale n.
26 del 1 febbraio 1997, nel quale la specialita' medicinale denominata "Dicloreum", a base di diclofenac sodico, nella confezione "CR" 20 capsule retard 150 mg, A.I.C. n. 024515114, della societa' Alfa Wassermann S.p.a., con sede in Alanno (Pescara), risulta classificata in classe c); Vista la domanda del 25 novembre 1996 con cui la societa' Alfa Wassermann S.p.a. chiede la riclassificazione in classe a) della specialita' medicinale denominata "Diclorreum", a base di diclofenac sodico, nella confezione "CR" 20 capsule retard 150 mg, al prezzo di L. 20.400, IVA compresa, riallineandosi al prezzodel farmaco di riferimento denominato "Dealgic", della societa' Poli industria chimica S.p.a., con sede in Milano; Vista la propria deliberazione, assunta nella seduta del 23 dicembre 1997, con la quale viene espresso parere favorevole all'inserimento in classe a) con nota 66 della specialita' medicinale denominata "Dicloreum", nella confezione "CR" 20 capsule retard 150 mg, al prezzo di L. 21.600 allineato, secondo quantita' di principio attivo, a quello del farmaco...
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