COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Coversyl» (19A01070)
Estratto determina IP n. 58 del 29 gennaio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del COVERSYL ARGININE 10 mg film-coated 30 tablets dall'Irlanda con numero di autorizzazione PA 0568/002/006, intestato alla societa' Les Laboratoires Servier e prodotto da Les Laboratoires Servier Industrie, da Servier (Ireland) Industries Ltd e da Anpharm Przedsiebiorstwo (Poland) con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta n. 2 - 20090 Segrate (MI). Confezione: COVERSYL «10 mg compresse rivestite con film» 30 compresse in contenitore per compresse PP. Codice A.I.C.: 047260029 (in base 10) 1F28CX (in base 32). Forma farmaceutica: compressa rivestita con film. Composizione: una compressa rivestita con film contiene: principio attivo: 6,790 mg di perindopril (corrispondenti a 10 mg di perindopril arginina);
eccipienti: nucleo della compressa: lattosio monoidrato, magnesio stearato, maltodestrina, silice colloidale idrofoba, sodio amido glicolato (tipo A);
rivestimento con film: glicerolo, ipromellosa, complessi rameici di clorofilline, macrogol 6000, magnesio stearato, titanio biossido. Officine di confezionamento secondario: CIT S.r.l., via Primo Villa n. 17 - 20875 Burago di Molgora (MB);
PB Beltracchini S.r.l., via S. Erasmo n. 6 - 20027 Rescaldina (MI);
XPO Supply Chain Pharma Italy S.p.a., via Amendola n. 1 - 20090 Caleppio di Settala (MI). Classificazione ai fini della rimborsabilita' Confezione: COVERSYL «10 mg compresse rivestite con film» 30 compresse in contenitore per compresse PP. Codice A.I.C.: 047260029. Classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art...
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