COMUNICATO - Importazione parallela del medicinale per uso umano «Elontril». (14A09677)
Estratto determina V &
A IP n. 2403 del 19 novembre 2014 E' autorizzata l'importazione parallela del medicinale ELONTRIL 150 mg comprimate cu eliberare modificată
30 compr. dalla Romania con numero di autorizzazione 4430/2012/02, il quale deve essere posto in commercio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione: Importatore: Four Pharma Cro S.r.l. Via Monti, 12 - 00034 Colleferro (RM) Confezione: ELONTRIL "150 mg compresse a rilascio modificato" 30 compresse in flacone HDPE Codice AIC: 043558016 (in base 10) 19K940 (in base 32) Forma Farmaceutica: compresse a rilascio modificato Ogni compressa contiene: Principio attivo: Bupropione cloridrato 150 mg;
Eccipienti: Nucleo della compressa: Alcol polivinilico, Gliceril dibeenato. Primo rivestimento: Etilcellulosa, Povidone K-90, Macrogol 1450 Secondo rivestimento: Macrogol 1450, Dispersione di copolimero di acido metacrilico etil acrilato (Eudragit L30 D-55), Silicio diossido, Trietilcitrato. Inchiostro da stampa nero Opacode S-1-17823 contenente fissante gomma lacca ~45% (20% esterificato) ferro ossido nero (E172) e ammonio idrossido 28%. Indicazioni terapeutiche Elontril e' indicato per il trattamento degli episodi di depressione maggiore. Confezionamento secondario E' autorizzato il confezionamento secondario presso l'officina De Salute S.r.l. Via Antonio Biasini, 26 - 26015...
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