COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Ugurol», con conseguente modifica degli stampati. (20A05214)
Estratto determina AAM/PPA n. 518/2020 del 16 settembre 2020 L'autorizzazione all'immissione in commercio del medicinale: UGUROL. Codice A.I.C.: 021458. Confezioni: 017 - «250 mg compresse» 20 compresse;
029 - «500 mg/5 ml soluzione iniettabile per uso endovenoso, per uso orale e locale» 5 fiale;
031 - «500 mg/5 ml soluzione iniettabile per uso orale e locale» 6 fiale. In adeguamento alla lista degli standard terms della Farmacopea europea e' inoltre autorizzata la modifica della denominazione della confezione: da: 031 - «500 mg/5 ml soluzione iniettabile, per uso orale e locale» 6 fiale;
a: 031 - «500 mg/5 ml soluzione iniettabile per uso endovenoso, per uso orale e locale» 6 fiale. Titolare A.I.C.: Rottapharm S.p.a., Galleria Unione, 5 - 20122 - Milano - codice fiscale 04472830159. Procedura: nazionale. Codice Pratica: FVRN/2010/1123. Con scadenza il 1° giugno 2010 e' rinnovata con validita' illimitata e con conseguente modifica del riassunto delle caratteristiche del prodotto, del foglio illustrativo e dell'etichettatura, a condizione che, alla data di entrata in vigore della presente determina, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Stampati Le modifiche devono essere apportate per il riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della presente determina mentre per il foglio illustrativo e l'etichettatura entro e non oltre sei mesi dalla medesima data. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni, il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in...
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