COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Harmonet» (19A04560)
Estratto determina IP n. 453 del 19 giugno 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale HARMONET «0,075 mg + 0,02 mg comprimidos revestidos» 3x21 Comprimidos dalla Portogallo con numero di autorizzazione 2493781, intestato alla societa' Laboratorios Pfizer LDA e prodotto da Farmalabor - Produtos Farmaceuticos S.A., da Haupt Pharma Munster GMBH e da Pfizer Ireland Pharmaceuticals con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farma 1000 S.r.l. con sede legale in via Camperio Manfredo, 9 - 20123 Milano. Confezione: HARMONET «0,075 mg + 0,02 mg compresse rivestite» 21 compresse. Codice A.I.C.: 038862025 (in base 10) 151Z69 (in base 32). Forma farmaceutica: compressa rivestita. Composizione: ciascuna compressa rivestita contiene: principio attivo: 0,075 mg di gestodene e 0,02 mg di etinilestradiolo. eccipienti: lattosio monoidrato, saccarosio (vedere paragrafo 2 «Harmonet contiene lattosio e saccarosio»), amido di mais, povidone K-25, magnesio stearato, povidone K-90, macrogol 6000, calcio carbonato, talco, cera E. Descrizione dell'aspetto di «Harmonet» e contenuto della confezione Le compresse di «Harmonet» sono compresse rivestite di colore bianco. «Harmonet» e' disponibile in confezioni contenenti ciascuna un blister in PVC/Al da 21 compresse, inserito all'interno di una bustina protettiva in alluminio, e 1 etichetta calendario adesiva da applicare sul blister al momento dell'utilizzo. Officine di confezionamento secondario De Salute S.r.l. via Biasini, 26 26015 Soresina (CR). Pharma Partners S.r.l. via E. Strobino, 55/57 - 59100 Prato (PO). S.C.F. S.r.l. via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO. Classificazione ai fini della rimborsabilita' Confezione: «Harmonet» «0,075 mg + 0,02 mg compresse rivestite» 21 compresse. Codice A.I.C.: 038862025. Classe di rimborsabilita': C(nn). La confezione...
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