COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Muscoril». (15A09037)
Estratto determina V&A IP n. 2124 del 10 novembre 2015 E' autorizzata l'importazione parallela del medicinale MUSCO-RIL solution for injection 4mg/2ml dalla GRECIA con numero di autorizzazione 45292/21-09-2009 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Farmaroc S.r.l. con sede legale in Viale Pio XI, n. 48, 70056 Molfetta (BA). Confezione: Muscoril "4mg/2ml soluzione iniettabile per uso intramuscolare" 6 fiale da 2 ml Codice AIC: 044131011 (in base 10) 1B2SQ3 (in base 32) Forma farmaceutica: soluzione iniettabile per uso intramuscolare Composizione: ogni fiala da 2ml contiene Principio attivo: Tiocolchicoside 4mg;
Eccipienti: sodio cloruro, acqua per uso iniettabile. Indicazioni terapeutiche: Trattamento adiuvante di contratture muscolari dolorose nelle patologie acute della colonna vertebrale negli adulti e negli adolescenti dai 16 anni in poi. Officine di confezionamento secondario Fiege logistics Italia S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI);
S.C.F. S.n.c. di Giovenzana Roberto e Pelizzola Mirko Claudio Via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO;
Falorni S.r.l. Via Provinciale Lucchese s.n.c. Loc. Masotti - 51100 Serravalle Pistoiese (PT);
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