COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Finasteride EG». (17A01991)
Estratto determina n. 390/2017 del 28 febbraio 2017 Medicinale: FINASTERIDE EG Titolare A.I.C.: EG S.p.a. - Via Pavia 6 - 20136 Milano. Confezione: «5 mg compresse rivestite con film» 90 compresse in blister pvc/pvdc/al;
A.I.C. n. 037837162 (in base 10) 142QCB (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: ogni compressa contiene: principio attivo: Finasteride. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1, che non siano classificate in fascia di rimborsabilita' ai sensi del presente articolo, risultano collocate, in virtu' dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, denominata classe C(nn). Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale Finasteride Eg e' la seguente: medicinali soggetti 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 determinazione. In ottemperanza all'art. 80 commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in...
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