COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Serenal» (19A03738)
Estratto determina IP n. 388 del 29 maggio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale SERENAL «15 mg comprimidos» 30 comprimidos dal Portogallo con numero di autorizzazione 8135327, intestato alla societa' BGP Products, Unipessoal Lda e prodotto da Haupt Pharma Munster GMBH, da Meda Manufacturing GMBH e da Meda Pharma GMBH &
Co. KG 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: SERPAX «15 mg compresse» 20 compresse. Codice A.I.C.: 047388018 (in base 10) 1F65CL (in base 32). Forma farmaceutica: compressa. Composizione: una compressa contiene: principio attivo: oxazepam 15 mg;
eccipienti: lattosio (vedere paragrafo serpax compresse contiene lattosio), magnesio stearato, amido di mais, amido pregelatinizzato. Come conservare «Serpax»: conservare a temperatura inferiore a 25°C. Officine di confezionamento secondario: Cit S.r.l. via Primo Villa n. 17 - 20875 Burago di Molgora (MB);
De Salute S.r.l. via Biasini, 26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: SERPAX «15 mg compresse» 20 compresse. Codice A.I.C.: 047388018. 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...
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