COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Exemestane Teva», con conseguente modifica degli stampati. (19A06976)
Estratto determina AAM/PPA n. 782/2019 del 4 ottobre 2019 L'autorizzazione all'immissione in commercio del medicinale: EXEMESTANE TEVA (A.I.C. 040275);
dosaggio/forma farmaceutica: «25 mg compresse rivestite con film» (tutte le confezioni autorizzate);
titolare A.I.C.: Teva Italia S.r.l. con sede legale e domicilio fiscale in piazzale Luigi Cadorna, 4 - 20123 - Milano (Italia) - codice fiscale/partita I.V.A. n. 11654150157;
codice procedura europea: UK/H/1900/001/R/001 (ora NL/H/4823/001);
codice pratica: FVRMC/2013/203, con scadenza il 31 luglio 2014 e' rinnovata con validita' illimitata e con conseguente modifica del riassunto delle caratteristiche del prodotto e del foglio illustrativo, 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 per il riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della presente determina mentre per il foglio illustrativo 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 commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare...
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