COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Alendros». (16A05828)
Estratto determina V&A n. 1181/2016 del 1° luglio 2016 Sono autorizzate le seguenti variazioni: C.I.4) Aggiornamento del paragrafo 4.4 del Riassunto delle caratteristiche del prodotto e relativo paragrafo del foglio illustrativo, con l'aggiunta degli «inibitori dell'angiogenesi» come fattore di rischio per l'osteonecrosi della mandibola;
modifiche del foglio illustrativo e delle etichette (Art. 61);
C.I.z) Aggiornamento dei paragrafi 4.4 e 4.8 del Riassunto delle caratteristiche del prodotto e paragrafo 4 del Foglio Illustrativo, a seguito delle raccomandazioni del PRAC del 10 settembre 2015, relative ai segnali di osteonecrosi del canale uditivo esterno per i medicinali contenenti bifosfonati, relativamente al medicinale «ALENDROS» nelle seguenti forme e confezioni: A.I.C. n. 029051063 - «70» 2 compresse in blister Al/Al da 70 mg;
A.I.C. n. 029051075 - «70» 4 compresse blister Al/Al da 70 mg;
A.I.C. n. 029051087 - «70» 8 compresse blister Al/Al da 70 mg;
A.I.C. n. 029051099 - «70» 12 compresse in blister Al/Al da 70 mg. Procedura: EMEA/H/xxxx/WS/0752, UK/H/0426/001/P/001 e EMEA/H/xxxx/WS/0862. Titolare AIC: Abiogen Pharma S.p.A.. 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 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...
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