COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Airol» (20A02231)
Estratto determina IP N. 68 del 29 gennaio 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale AIROL CREAM 0,05% TUB X 20 g dalla Grecia con numero di autorizzazione 8555/6-2-2007, intestato alla societa' Pierre Fabre Hellas AE Leof. Mesogeion 350 &
Thrakis 64,153 41, Agia Paraskeyi Greece e prodotto da Pierre Fabre Medicament Production, Etablissment progipharm, Rue Du Lycee Gien Cedex France, 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: «Airol» - 0,5 mg/g crema - tubo 20 g - codice A.I.C. n. 048300014 (in base 10) 1G1ZZG (in base 32). Forma farmaceutica: crema. Composizione: un grammo di crema contiene: principio attivo: 0,5 mg di tretinoina (Vitamina A-acido);
eccipienti: Glicerolo stearato/Ceteareth 20, Peridrosqualene, Cetilesteri, Sorbitolo liquido (E420),Magnesio solfato, Acido benzoico (E210), Butilidrossianisolo (E320), Disodio edetato, acqua depurata. Officine di confezionamento secondario: Pharma Partners S.r.l., via E. Strobino n. 55/57 - 59100 Prato (PO);
Xpo Supply Chain Pharma Italy S.p.a., via Amendola n. 1 - 20090 Settala (MI);
De Salute S.r.l., via Biasini n.26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: «Airol» - 0,5 mg/g crema - tubo 20 g - codice A.I.C. n. 048300014. 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...
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