COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Sirdalud» (19A00272)
Estratto determina IP n. 857 del 17 dicembre 2018 E' autorizzata l'importazione parallela del medicinale SIRDALUD 2 mg tabletten - 100 tabletten dalla Germania con numero di autorizzazione 4844.00.00, intestato alla societa' Novartis Pharma GmbH e prodotto da Novartis Pharma GmbH (DE), da SanofiSynthelabo GmbH (DE) e da Novartis Pharma Produktions GmbH (DE), 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, 9 - 20123 Milano (MI). Confezione: SIRDALUD «2 mg compresse» 20 compresse. Codice A.I.C.: 046985014 (in base 10) - 1DTVTQ (in base 32). Forma farmaceutica: compressa. Composizione: una compressa contiene: principio attivo: tizanidina cloridrato 2,288 mg pari a 2,00 mg di tizanidina base;
eccipienti: silice colloidale anidra, acido stearico, cellulosa microcristallina, lattosio anidro. Conservazione: non conservare a temperatura superiore ai 25°C. Officine di confezionamento secondario Kohlpharma GmbH Irm Holzhau 8 - 66663 Merzig (Germania);
S.C.F. S.r.l. via F. Barbarossa,7 - 26824 Cavenago D'Adda Lodi;
XPO Supply Chain Pharma Italy S.p.A. via Amendola, 1 Settala loc. Caleppio 20090 Milano;
De Salute S.r.l. via Biasini, 26 - 26015 Soresina Cremona. Classificazione ai fini della rimborsabilita' Confezione: «Sirdalud» - 2 mg compresse - 20 compresse. Codice A.I.C.: 046985014. 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...
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