COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Maalox». (15A01995)
Estratto determina V&A IP n. 307 del 16 febbraio 2015 E' autorizzata l'importazione parallela del medicinale MAALOX PLUS 40 Comprimidos para mastigar dal Portogallo con numero di autorizzazione 5490578, 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: Gekofar S.r.l., con sede legale in piazza Duomo n. 16 - 20122 Milano. Confezione: «Maalox Plus» compresse masticabili 30 compresse;
codice A.I.C.: 041615030 (in base 10), 17PZPQ (in base 32). Forma farmaceutica: compresse masticabili. Composizione: ogni compressa contiene: principi attivi: magnesio idrossido 200 mg;
alluminio ossido idrato 200 mg;
dimeticone 25 mg;
eccipienti: amido di mais;
acido citrico;
amido di mais pregelatinizzato;
glucosio;
mannitolo;
saccarosio;
sorbitolo, talco;
magnesio stearato;
saccarina sodica;
aroma di limone;
aroma di crema svizzera;
ossido di ferro giallo (E 172). Indicazioni terapeutiche: trattamento sintomatico del bruciore e dell'iperacidita' dello stomaco occasionali. Confezionamento secondario: e' autorizzato il confezionamento secondario presso l'officine Fiege Logistics Italia S.p.a., via Amendola n. 1 - 20090 Caleppio di Settala...
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