COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Glucompet», con conseguente modifica stampati. (18A01873)
Estratto determina AAM/PPA n. 98/2018 del 2 febbraio 2018 L'autorizzazione all'immissione in commercio del medicinale: GLUCOMPET. Confezioni: A.I.C. n. 038827 010 «250 MBq/ML soluzione iniettabile» 1 flaconcino monodose;
A.I.C. n. 038827 022 «250 MBq/ML soluzione iniettabile» 1 flaconcino multi dose da 10 ml contenente da 0,8 a 10 ml. Titolare AIC: A.C.O.M. Advanced Center Oncology Macerata S.r.l. Procedura nazionale con scadenza il 4 luglio 2015 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del riassunto delle caratteristiche del prodotto, del foglio illustrativo e dell'etichettatura ed a condizione che, alla data di entrata in vigore della presente determinazione, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Le modifiche devono essere apportate immediatamente per il riassunto delle caratteristiche del prodotto mentre per il foglio illustrativo ed etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determinazione. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella provincia di Bolzano, anche in lingua tedesca. Il titolare dell'AIC che intende avvalersi dell'uso complementare di lingue estere, deve...
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