COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Sirdalud» (17A07297)
Estratto determina IP n. 485 del 20 settembre 2017 E' autorizzata l'importazione parallela del medicinale SIRDALUD 4 mg 100 tabletten PVC/PE/PVdC/Al blisterpackung dalla Germania con numero di autorizzazione 4844.01.00con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Pricetag S.p.a. con sede legale in Vasil Levski St. 103 - 1000 Sofia;
Confezione: «Sirdalud 4 mg compresse» 30 compresse. Codice A.I.C. n. 045415015 (in base 10) 1C9YM7 (in base 32). Forma farmaceutica: compresse. Composizione: una compressa contiene: principio attivo: tizanidina cloridrato 4,576 mg, pari a tizanidina 4 mg. Eccipienti: silice colloidale anidra, acido stearico, cellulosa microcristallina, lattosio. Indicazioni terapeutiche: Spasmi muscolari dolorosi: associati a disordini statici e funzionali della colonna vertebrale (sindromi artrosiche cervicali e lombari, torcicollo, lombalgie, ecc.);
conseguenti ad interventi chirurgici (ernia del disco, artrosi dell'anca, ecc.). Spasticita' conseguente a disordini neurologici: es. sclerosi multipla, mielopatia cronica, malattie degenerative del midollo spinale, incidenti vascolari cerebrali. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI);
S.C.F. S.n.c. Di Giovenzana Roberto e Pelizzola Mirko...
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