COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Zopiclone EG» (14A01807)
Estratto determinazione n. 184/2014 del 27 febbraio 2014 Medicinale: ZOPICLONE EG. Titolare A.I.C.: EG S.p.A. - Via D. Scarlatti, 31 - 20124 Milano. Confezioni: «7,5 mg compresse rivestite con film» 18 compresse in blister PVC/PVDC/AL - A.I.C. n. 034398180 (in base 10) 10TRZ4 (in base 32);
7,5 mg compresse rivestite con film
250 compresse in flacone PP - A.I.C. n. 034398192 (in base 10) 10TRZJ (in base 32);
7,5 mg compresse rivestite con film
1000 compresse in flacone PP - A.I.C. n. 034398204 (in base 10) 10TRZW (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: ogni compressa rivestita con film contiene: principio attivo: 7,5 mg di zopiclone. Classificazione Le confezioni di cui all'art. 1 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 ZOPICLONE e' la seguente. Per le confezioni fino ad un massimo di 30 compresse: medicinale soggetto a prescrizione medica (RR). Per le confezioni superiori a 30 compresse: uso riservato agli ospedali, alle cliniche e alle case di cura. Vietata la vendita al pubblico (OSP). 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 successive modifiche ed...
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