COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Vasoretic» (15A02706)
Estratto determina V&A IP n. 570 del 20 marzo 2015 E' autorizzata l'importazione parallela del medicinale CO-RENITEC 20 mg + 12,5 mg tablet 28 Tabs Al/Al blister dall'Ungheria con numero di autorizzazione OGYI-T-8234/02, 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: New Pharmashop S.r.l. CIS di Nola Isola 1 - Torre 1 - Int. 120 - 80035 Nola. Confezione: Vasoretic "20 mg + 12,5 mg compresse" 14 compresse. Codice AIC: 043347020 (in base 10) 19BV2B (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, amido pregelatinizzato, ossido di ferro giallo (E172), magnesio stearato. Indicazioni terapeutiche: Trattamento dell'ipertensione in pazienti per i quali e' indicata l'associazione terapeutica. Confezionamento secondario. E' autorizzato il confezionamento secondario presso le officine Pharm@Idea S.r.l. via del Commercio, 5 - 25039 Travagliato (BS);
S.C.F. S.n.c. Di Giovenzana Roberto e Pelizzola Mirko Claudio via F. Barbarossa, 7 - 26824 Cavenago d'Adda - LO;
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