COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Totalip» (20A01137)
Estratto determina AAM/PPA n. 75 del 3 febbraio 2020 Si autorizza la seguente variazione: tipo II C.I.4), aggiornamento dei paragrafi 4.2, 4.4. e 4.5 del riassunto delle caratteristiche del prodotto e delle corrispondenti sezioni del foglio illustrativo per includere informazioni sulla possibilita' di interazioni a seguito della co-somministrazione di atorvastatina e letermovir;
implementazione dello PSUSA atorvastatina/ezetimibe con aggiornamento della sezione 4 del foglio illustrativo;
aggiornamento dei paragrafi 2, 4.2., 4.3, 4.6, 4.8, 5.1 del riassunto delle caratteristiche del prodotto e delle corrispondenti sezioni del foglio illustrativo per modifiche editoriali minori o di adeguamento al QRD template;
inserimento dell'avvertenza relativa al contenuto di sodio, in accordo all'Annex della linea guida degli eccipienti attualmente in vigore. Le suddette variazioni sono relative al medicinale TOTALIP nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Numero procedura: IT/H/299/01-008/II/034. Codice pratica: VC2/2019/372. Titolare A.I.C.: Laboratori Guidotti S.p.a (codice fiscale 00678100504). 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 modifiche e integrazioni, il foglio illustrativo e le etichette devono essere redatti in...
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