COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Malarone» (19A03118)
Estratto determina IP n. 291 del 16 aprile 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale MALARONE «250/100 mg filmohulde tabletten» 12 tabletten dai Paesi Bassi con numero di autorizzazione RVG 25386, intestato alla societa' Glaxosmithkline BV e prodotto da Aspen Bad Oldesloe Gmbh e da Glaxo Wellcome S.A., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta, 2 - 20090 Segrate (MI). Confezione: MALARONE «250 mg/100 mg compresse rivestite con film» 12 compresse in blister PVC/AL;
codice A.I.C. n.: 047466014 (in base 10) 1F8KJY (in base 32);
forma farmaceutica: compressa rivestita;
composizione: ciascuna compressa rivestita contiene: principio attivo: 250 mg di atovaquone e 100 mg di proguanile cloridrato;
eccipienti: nucleo della compressa: polossamero 188, cellulosa microcristallina, idrossipropilcellulosa, povidone K30, carbossimetilamido sodico (tipo A), magnesio stearato rivestimento della compressa: ipromellosa, titanio diossido (E171), ferro ossido rosso (E172), macrogol 400 e polietilenglicole 8000 (vedere paragrafo 2). Officine di confezionamento secondario: Pharma Partners S.r.l., via E. Strobino, 55/57 - 59100 Prato (PO);
De Salute S.r.l., via Biasini, 26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: MALARONE «250 mg/100 mg compresse rivestite con film» 12 compresse in blister PVC/AL;
codice A.I.C. n.: 047466014;
classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «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), nelle more della...
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