COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Nootropil» (20A01127)
Estratto determina IP n. 34 del 21 gennaio 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale NOOTROPIL 1200 mg film-coated tablets 60 tablets dall'Ungheria con numero di autorizzazione OGYI-T-1752/09, intestato alla societa' UCB Magyarorszag KFT con sede in H-1023 Budapest Arpad Fejedelem utja 26-28., Hungary e prodotto da UCB Pharma SA - Chemin Du Foriest, B-1420 Braine-I'Alleud, Belgium, 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 2 - 20090 Segrate MI. Confezione: NOOTROPIL «1200 mg compresse rivestite con film» 40 compresse. Codice A.I.C. n. 048298020 (in base 10) 1G1Y14 (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: una compresse rivestite con film contiene: principio attivo: 1200 mg di piracetam;
eccipienti: nucleo: macrogol 6000, silice colloidale anidra, magnesio stearato, croscarmellosa sodica. Rivestimento: Opadry Y-1-7000, composto da: ipromellosa, titanio diossido, macrogol 400;
Opadry OY-S-29019 Clear, composto da: ipromellosa e macrogol 6000. Officine di confezionamento secondario: S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago d'Adda - LO;
De Salute S.r.l., via Biasini, 26 - 26015 Soresina (CR);
Xpo Supply Chain Pharma Italy S.p.a., via Amendola, 1 - 20090 Caleppio di Settala (MI). Classificazione ai fini della rimborsabilita' Confezione: NOOTROPIL «1200 mg compresse rivestite con film» 40 compresse. Codice A.I.C. n. 048298020. Classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della legge 24...
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