COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Brusonex» (19A08097)
Estratto determina AAM/PPA n. 1040/2019 del 16 dicembre 2019 Descrizione del medicinale e attribuzione numero A.I.C.: B.II.e.5.d - L'immissione in commercio del medicinale BRUSONEX (A.I.C. n. 042763) e' autorizzata anche nella forma e confezione di seguito indicata, in aggiunta alle confezioni gia' approvate: confezione: «50 microgrammi/erogazione spray nasale, sospensione» 1 flacone in hdpe da 10g (60 erogazioni) - A.I.C. n. 042763033 (base 10) - 18T0ST (base 32);
forma farmaceutica: spray nasale, sospensione. Principio attivo: mometasone furoato. Titolare A.I.C.: Bruschettini S.r.l. (codice fiscale 0265870105) con sede legale e domicilio fiscale in via Isonzo, 5 - cap 16147 Genova - Italia. Codice pratica: C1B/2019/1811. Classificazione ai fini della rimborsabilita' Per la confezione di cui sopra, e' adottata la classificazione ai fini della rimborsabilita': Classe C(nn). Classificazione ai fini della fornitura Per la confezione di cui all'art. 1 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...
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