COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Azzalure» (17A03254)
Estratto determina AAM/PPA n. 436 del 28 aprile 2017 Autorizzazione delle variazioni: variazione di tipo II:C.I.6.a Aggiunta di una nuova indicazione terapeutica;
ulteriori modifiche degli stampati, relativamente al medicinale AZZALURE;
Numero di procedura: n. FR/H/0341/001/II/033. Sono autorizzate le indicazioni terapeutiche come di seguito indicato: «Azzalure e' indicato per il miglioramento temporaneo dell'aspetto di: rughe d'espressione glabellari (rughe verticali tra le sopracciglia) osservabili al massimo corrugamento della fronte e/o rughe cantali laterali (zampe di gallina) osservabili al massimo sorriso di grado da moderato a severo, in soggetti adulti d'eta' inferiore a 65 anni, quando la severita' di tali rughe ha un importante impatto psicologico per il paziente.». Ulteriori modifiche degli stampati, relativamente al medicinale «Azzalure», nelle forme e confezioni: A.I.C. n. 039063019 - «10 unita' Speywood/0,05 ml polvere per soluzione iniettabile» un flaconcino da 125 unita' Speywood;
A.I.C. n. 039063021 - «10 unita' Speywood/0,05 ml polvere per soluzione iniettabile» 2 flaconcini da 125 unita' Speywood. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Ipsen S.p.a, con sede legale e domicilio fiscale in Assago - Milano (MI), via Del Bosco Rinnovato , 6, Milanofiori nord, Palazzo U7, c.a.p. 20090, Italia, codice fiscale 05619050585. Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determinazione al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo e all'etichettatura. 2. In...
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