COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Adalat Crono» (17A01934)
Estratto determina IP n. 155 del 21 febbraio 2017 E' autorizzata l'importazione parallela del medicinale «Adalat Oros» 30 mg comprimidos de liberacion prolongada 28 comp. dalla Spagna con numero di autorizzazione 59538 C.N. 750992-9 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: Pricetag Spa, con sede legale in Vasil Levski St. 103 - 1000 Sofia. Confezione: ADALAT CRONO «30 mg compresse a rilascio modificato» 14 compresse. Codice A.I.C.: 044937047 (in base 10) 1BVCUR (in base 32). Forma farmaceutica: compresse a rilascio modificato. Composizione: ogni compresse a rilascio modificato contiene: principio attivo: nifedipina 30 mg;
eccipienti: polietilene ossido, ipromellosa, magnesio stearato, sodio cloruro, ferro ossido rosso;
ipromellosa;
cellulosa acetato;
macrogol;
idrossipropilcellulosa;
titanio diossido;
glicole propilenico, ferro ossido nero (E 172). Indicazioni terapeutiche: 1) trattamento della cardiopatia ischemica: angina pectoris cronica stabile (angina da sforzo);
2) trattamento dell'ipertensione arteriosa. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.A., via Amendola n. 1 - 20090 Caleppio di Settala (Milano);
S.C.F. S.n.c. Di Giovenzana Roberto e Pelizzola Mirko Claudio, via F. Barbarossa n. 7 - 26824 Cavenago D'Adda (Lodi);
Falorni s.r.l., via Provinciale Lucchese n. 51 - Loc. Masotti 51030...
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