COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Exocin» (20A01128)
Estratto determina IP n. 59 del 22 gennaio 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale EXOCIN 3 mg/ml colirio, solucao dalla Portogallo con numero di autorizzazione 2427581, intestato alla societa' Allergan S.A.Plaza Da La Encina - Edificio La Encina 10-11 Tres Cantos 28760 Espanha e prodotto da Allergan Pharmaceuticals Ireland Castelbar Road Westport-Conty Mayo - Irlanda, 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: EXOCIN «3 mg/ml collirio, soluzione» 1 flacone da 10 ml. Codice A.I.C. n. 048241018 (in base 10) 1G06CU (in base 32). Forma farmaceutica: collirio, soluzione. Composizione: 1 ml di soluzione contiene: principio attivo: 3 mg di ofloxacina;
eccipienti: benzalconio cloruro, sodio cloruro, idrossido di sodio e acido cloridrico per l'aggiustamento del pH, acqua depurata. Come conservare EXOCIN: conservare a temperatura inferiore a 25°C. Officine di confezionamento secondario: Falorni S.rl. - via Provinciale Lucchese S.n.c. - loc. Masotti - 51034 Serravalle Pistoiese (PT);
Pharma Partners S.r.l. - via Ettore Strobino n. 55/57 - 59100 Prato;
De Salute S.r.l. - via Antonio Biasini n. 26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: EXOCIN «3 mg/ml collirio, soluzione» 1 flacone da 10 ml. Codice A.I.C. n. 048241018. 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...
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