COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Vasoretic». (15A05114)
Estratto determina V&A IP n. 1143 del 12 giugno 2015 E' autorizzata l'importazione parallela del medicinale CO-RENITEC 20 mg + 12,5 mg comprimidos 28 comprimidos dalla Spagna con numero di autorizzazione 59286 Codigo Nacional 895003-4, il quale, per le motivazioni espresse in premessa, deve essere posto in commercio con la denominazione Vasoretic e 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: VASORETIC «20 mg + 12,5 mg compresse» 14 compresse;
Codice A.I.C.: 043892013 (in base 10) 19VH9F (in base 32). Forma farmaceutica: compresse. Ogni compressa contiene: Principi attivi: enalapril maleato 20 mg;
idroclorotiazide 12,5 mg;
Eccipienti: sodio bicarbonato, lattosio monoidrato, amido di mais senza glutine, amido di mais pregelatinizzato, ossido di ferro giallo (E172), magnesio stearato. Indicazioni terapeutiche: trattamento dell'ipertensione in pazienti per i quali e' indicata l'associazione terapeutica. 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'...
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