COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Voltaren». (15A05113)
Estratto determina V&A IP n. 1142 del 12 giugno 2015 E' autorizzata l'importazione parallela del medicinale VOLTAREN Retard 75 mg comprimidos de liberacion modificada 40 compr. dalla Spagna con numero di autorizzazione 62024 Codigo Nac. 655134-9, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione. Importatore: Medifarm S.r.l., via Tiburtina nn. 1166/1168, 00156 Roma. Confezione: VOLTAREN «75 mg compresse a rilascio prolungato» 30 compresse. Codice A.I.C.: 041671025 (in base 10) 17RQCK (in base 32). Forma farmaceutica: compresse a rilascio prolungato. Una compressa contiene: Principio attivo: diclofenac sodico 75 mg. Eccipienti: saccarosio;
silice colloidale anidra;
povidone;
magnesio stearato;
alcool cetilico;
ipromellosa;
polisorbato 80;
titanio diossido;
ferro ossido rosso;
talco. Indicazioni terapeutiche Malattie reumatiche infiammatorie e degenerative quali: artrite reumatoide, spondilite anchilosante;
artrosi;
reumatismi non articolari. Dolori da infiammazione di origine non reumatica o a seguito di un trauma. Trattamento di dolori mestruali. Officina di confezionamento secondario: Mediwin Limited, Unit 12-13 Martello Enterprise Centre Courtwick Lane - Littlehampton West Sussex BN17 7PA, Regno Unito;
Classificazione ai fini della rimborsabilita': Confezione: VOLTAREN «75 mg compresse a...
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