COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Novalgina» (20A04729)
Estratto determina IP n. 503 del 1° settembre 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale NOVALGINE 500 mg/mldruppels voor oraal gebruik, oplossing 20 ml dal Belgio con numero di autorizzazione BE067995, intestato alla societa' Sanofi Belgium Leonardo da Vincilaan 19 1831 Diegem Belgium e prodotto da Nattermann &
Cie GmbH Nattermannallee 1 50829 Köln Germany, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farma 1000 S.r.l. con sede legale in via Camperio Manfredo n. 9, 20123 Milano. Confezione: NOVALGINA «500 mg/ml gocce orali, soluzione» flacone 20 ml. Codice A.I.C.: 048739015 (in base 10) 1GHDQ7(in base 32). Forma farmaceutica: 500 mg/ml gocce orali, soluzione. Composizione: 1 ml di soluzione contiene. Principio attivo: noramidopirina metansolfonato sodico (metamizolo) 500 mg. Eccipienti: disodio idrogeno fosfato dodecaidrato, sodio idrogeno fosfato diidrato, saccarina sodica, olio misto 50/50 e acqua depurata. Officine di confezionamento secondario: De Salute S.r.l., via Biasini n. 26, 26015 Soresina (CR);
S.C.F. S.r.l., via F. Barbarossa n. 7, 26824 Cavenago d'Adda - LO. Classificazione ai fini della rimborsabilita' Confezione: NOVALGINA «500 mg/ml gocce orali, soluzione» flacone 20 ml. Codice A.I.C.: 048739015. 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 presentazione da parte del titolare...
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