COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Muscoril» (19A06615)
Estratto determina IP n. 696 del 2 ottobre 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale MUSCORIL cps 4 mg capsule, hard 30 capsule dalla Repubblica Ceca con numero di autorizzazione 63/168/98-c, intestato alla societa' Sanofi-Aventis S.R.O. e prodotto da Famar Healthcare Sevices Madrid, S.A.U. e da Sanofi Winthrop Industrie (FR), 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 n. 2 - 20090 Segrate (MI). Confezione: MUSCORIL «4 mg capsule rigide» 30 capsule in blister PVC/AL - codice A.I.C. n. 044005041 (in base 10) 19YXPK (in base 32). Forma farmaceutica: compressa rigida. Composizione: una compressa rigida contiene: principio attivo: 4 mg di tiocolchicoside;
eccipienti: lattosio monoidrato, amido di mais, magnesio stearato;
eccipiente dell'involucro: gelatina (capsula trasparente);
inchiostro di stampa: ossido di ferro (rosso) E172, etanolo anidro, gommalacca naturale, acqua purificata, alcol isopropilico, glicole propilenico, butanolo, soluzione di ammoniaca concentrata, idrossido di potassio. Conservazione: conservare a temperatura inferiore a 25°C. Officine di confezionamento secondario: Falorni s.r.l. via Provinciale Lucchese, localita' Masotti 51030 Serravalle Pistoiese (PT);
Pharma Partners s.r.l. via E. Strobino nn. 55/57 - 59100 Prato (PO);
S.C.F. s.r.l. via F. Barbarossa n. 7 - 26824 Cavenago d'Adda - LO. Classificazione ai fini della rimborsabilita' Confezione: MUSCORIL «4 mg capsule rigide» 30 capsule in blister PVC/AL - codice A.I.C. n. 044005041;
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...
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