COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Dicloreum Unidie» (18A01976)
Estratto determina AAM/PPA n. 227/2018 del 6 marzo 2018 Codice pratica: N1B/2017/1576. E' autorizzata l'immissione in commercio del medicinale DICLOREUM UNIDIE anche nella forma farmaceutica/dosaggio e confezioni di seguito indicate, in aggiunta alle confezioni gia' autorizzate: confezione: «136 mg cerotto medicato» 4 cerotti - A.I.C. n. 037184037 (base 10) 13GSK5 (base 32);
confezione: «136 mg cerotto medicato» 8 cerotti - A.I.C. n. 037184049 (base 10) 13GSKK (base 32). Principio attivo: Ibuprofene. Titolare A.I.C.: Alfasigma S.p.a. con sede legale e domicilio fiscale in viale Sarca n. 223, 20126 Milano - Italia (codice fiscale 03432221202). Classificazione ai fini della rimborsabilita' Per le confezioni sopracitate e' adottata la seguente classificazione ai fini della rimborsabilita': classe C. Classificazione ai fini della fornitura Per le confezioni sopracitate e' adottata la seguente classificazione ai fini della fornitura: SOP: medicinale non soggetto a prescrizione medica ma non da banco. Stampati Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come precedentemente autorizzati...
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