COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Feldene». (20A00112)
Estratto determina AAM/PPA n. 1049 del 18 dicembre 2019 Si autorizza la seguente variazione: Tipo II, C.I.4) - Modifica degli stampati, par. 4.4 del RCP e corrispondente sezione del FI, per adeguamento al CCDS (versione 14 del 15 agosto 2018);
adeguamento per gli eccipienti ad effetto noto nelle diverse formulazioni, secondo la Linea Guida europea in materia di eccipienti (SANTE-2017-11668);
modifiche di adeguamento al QRD template, versione corrente, al par. 4.8 del RCP e corrispondente sezione del FI, relativamente al medicinale FELDENE, nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia, a seguito di procedura nazionale: A.I.C. n.: 024249029 - «20 mg capsule rigide» 30 capsule;
024249031 - «20 mg supposte» 10 supposte;
024249056 - «20 mg compresse solubili» 30 compresse;
024249068 - «20 mg/1 ml soluzione iniettabile per uso intramuscolare» 6 fiale 1 ml. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Codice pratica: VN2/2018/318. Titolare di A.I.C.: Pfizer Italia S.r.l. (codice fiscale 06954380157). Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo. 2. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni e 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...
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