COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Mercilon» (19A02876)
Estratto determina IP n. 175 del 2 aprile 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale Mercilon 0,15 mg + 0,02 mg tabletten 21 × 3 tabletten dai Paesi Bassi con numero di autorizzazione RVG 11508, intestato alla societa' N.V. Organon e prodotto da N.V. Organon e da Organon (Ireland) Limited, 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: MERCILON «0,15 mg + 0,02 mg compresse» 21 compresse. Codice A.I.C. n. 047268014 (in base 10) 1F2J5G (in base 32). Forma farmaceutica: compressa. Composizione: una compressa contiene: principio attivo: desogestrel (0,150 mg) ed etinilestradiolo (0,020 mg);
eccipienti: silice colloidale anidra, lattosio monoidrato, amido di patate, povidone, acido stearico, alfa-tocoferolo. Descrizione dell'aspetto di «Mercilon» e contenuto della confezione: «Mercilon» e' disponibile in confezioni da 1, 3 o 6 blister da 21 compresse, inseriti in una bustina di alluminio e confezionati in una scatola contenente una etichetta calendario adesiva da applicare sul blister al momento dell'utilizzo. Officine di confezionamento secondario: S.C.F. S.r.l. via F. Barbarossa, 7 - 26824 Cavenago d'Adda (LO);
Pharma Partners S.r.l. via E. Strobino, 55/57 - 59100 Prato (PO). Classificazione ai fini della rimborsabilita' Confezione: MERCILON «0,15 mg + 0,02 mg compresse» 21 compresse. Codice A.I.C. n. 047268014. 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 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non...
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