COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Mictonorm». (17A04776)
Estratto determina AAM/PPA n. 697 del 26 giugno 2017 E' autorizzata l'immissione in commercio del medicinale MICTONORM, anche nelle forme e confezioni di seguito indicate. Confezioni: «15 mg compresse rivestite» 84 compresse in blister PVC/AL;
A.I.C. n. 037768621 (base 10) 140MFF (base 32);
15 mg compresse rivestite
168 compresse in blister PVC/AL;
A.I.C. n. 037768633 (base 10) 140MFT (base 32);
15 mg compresse rivestite
252 compresse in blister PVC/AL;
A.I.C. n. 037768645 (base 10) 140MG5 (base 32). Forma farmaceutica: compressa rivestita. Principio attivo: propiverina cloridrato. Titolare A.I.C.: Apogepha Arzneimittel GMBH, con sede legale e domicilio fiscale in Kyffhäuserstrasse, 27 - 01309 Dresden - Germania. 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 le confezioni sopracitate e' adottata la seguente classificazione ai fini della fornitura: RR medicinali 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 modificazioni e integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio...
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