COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Finasteride Ipso Pharma». (20A01092)
Estratto determina n. 180/2020 del 12 febbraio 2020 Medicinale: FINASTERIDE IPSO PHARMA. Titolare A.I.C.: Ipso Pharma Srl - via S. Rocco n. 6 - 85033 Episcopia (PZ). Confezione: «5 mg compresse rivestite con film» 30 compresse in blister opaco PVC/PE/PVDC e alluminio - A.I.C. n. 038412021 (in base 10). Forma farmaceutica: compresse rivestite con film. Composizione: principio attivo: finasteride. Classificazione ai fini della rimborsabilita' Confezione: «5 mg compresse rivestite con film» 30 compresse in blister opaco PVC/PE/PVDC e alluminio - A.I.C. n. 038412021 (in base 10);
classe di rimborsabilita': «A»;
prezzo ex factory (IVA esclusa): euro 7,65;
prezzo al pubblico (IVA inclusa): euro 14,34. Validita' del contratto: ventiquattro mesi. Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale «Finasteride Ipso Pharma» (finasteride) e' la seguente: medicinale soggetto a prescrizione medica (RR). Stampati Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come precedentemente autorizzati da questa amministrazione, con le sole modifiche necessarie per l'adeguamento alla presente determina. In ottemperanza all'art. 80, commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare dell'A.I.C. che intende avvalersi dell'uso...
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