PROVVEDIMENTO 22 giugno 1998 - Riclassificazione della specialita' medicinale "Rinovagos"
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 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 ministeriale 25 luglio 1997, pubblicato nella Gazzetta Ufficiale del 13 ottobre 1997, n. 239, supplemento ordinario n. 208, nel quale la specialita' medicinale denominata "Rinovagos", a base di ipatropio bromuro, della societa' Valeas Industria chimica farmaceutica S.p.a., con sede in Milano, nella confezione 1 flac.
erogatore 200 dosi 0,02 mg/dose, A.I.C. n. 029509015, risulta classificata in classe b) al prezzo di L. 9.000, IVA compresa; Vista la domanda del 27 febbraio 1998, con la quale la societa' Boehringer Ingelheim Italia S.p.a., con. sede in Firenze, chiede la riclassificazione in classe b) al prezzo di L. 10.100 della specialita' medicinale denominata "Atrovent", a base di ipatropio bromuro, nella confezione spray nasale flac. 15 ml 0,03%, AIC n.
029308032, allineandosi all'analoga specialita' medicinale denominata "Rinovagos", nella confezione sopra citata; Vista la propria deliberazione, assunta nella seduta del 13 maggio 1998, con la quale e' stata riconfermata la classificazione in classe c) della specialita' medicinale...
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