COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Estinette» (19A04366)
Estratto determina IP n. 409 dell'11 giugno 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale ESTINETTE «75 microgramas/ 20 microgramas comprimidos revestidos» 63 comprimidos dal Portogallo con numero di autorizzazione 5994280, intestato alla societa' Laboratorios Effik, Sociedade Unipessoal e prodotto da Gedeon Richter Plc., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: New Pharmashop s.r.l. con sede legale in Cis di Nola Isola 1, torre 1, int. 120 - 80035 Nola (NA). Confezione: ESTINETTE «0,075 mg + 0,020 mg compresse rivestite» 21 compresse in blister PVC/PVDC/AL. Codice A.I.C.: 047632017 (in base 10) 1FFMNK (in base 32). Forma farmaceutica: compressa rivestita. Composizione: una compressa rivestita contiene: principio attivo: 75 microgrammi di gestodene e 20 microgrammi di etinilestradiolo;
eccipienti: nucleo della compressa: sodio calcio edetato, magnesio stearato, silice colloidale anidra, povidone K-30, amido di mais, lattosio monoidrato. Rivestimento: giallo chinolina (E104), povidone K-90, titanio diossido (E171), macrogol 6000, talco, calcio carbonato (E170), saccarosio. Officine di confezionamento secondario: S.C.F. s.r.l., via F. Barbarossa n. 7 - 26824 Cavenago D'Adda - LO;
Pharma Partners s.r.l., via E. Strobino nn. 55/57 - 59100 Prato (PO);
Pharm@Idea s.r.l., via del Commercio n. 5 - 25039 Travagliato (BS). Classificazione ai fini della rimborsabilita' Confezione: ESTINETTE «0,075 mg + 0,020 mg compresse rivestite» 21 compresse in blister PVC/PVDC/AL. Codice A.I.C.: 047632017. Classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10...
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