COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Sodio cloruro S.A.L.F.» (17A05384)
Estratto determina AAM/PPA n. 751 del 12 luglio 2017 E' autorizzata l'immissione in commercio del medicinale SODIO CLORURO S.A.L.F., anche nella forma e confezione di seguito indicata. Codice pratica N1B/2017/124. Confezione: «0,9% solvente per uso parenterale» 5 fiale in vetro da 2 ml - A.I.C. n. 030684664 (in base 10) 0X8FHS (in base 32). Forma farmaceutica: solvente per uso parenterale. Principio attivo: sodio cloruro. Titolare A.I.C.: S.A.L.F. S.p.A. Laboratorio farmacologico (Codice fiscale 00226250165) con sede legale e domicilio fiscale in via Marconi, 2 - 24069 Cenate Sotto - Bergamo (Italia). Classificazione ai fini della rimborsabilita' Per la confezione sopracitata e' adottata la seguente classificazione ai fini della rimborsabilita': apposita sezione della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', denominata classe «C (nn)». Classificazione ai fini della fornitura Per la confezione sopracitata e' adottata la seguente classificazione ai fini della fornitura: SOP - medicinali non soggetti a prescrizione medica. Stampati La confezione del medicinale deve essere posta in commercio con gli stampati, cosi' come precedentemente autorizzati da questa Amministrazione, con le sole modifiche necessarie per l'adeguamento alla determinazione, di cui al presente estratto. In ottemperanza all'art. 80, commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e successive modifiche ed integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana...
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