COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Venoruton» (18A02237)
Estratto determina AAM/PPA n. 206 del 2 marzo 2018 Autorizzazione della variazione. Variazioni di tipo II: C.I.4 Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza, relativamente al medicinale VENORUTON. Codice pratica: VN2/2017/384. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto alla sezione 4.2 e corrispondente paragrafo del foglio illustrativo, relativamente al medicinale «Venoruton», nelle forme e confezioni sottoelencate: A.I.C. n. 017076112 - «500 mg compresse effervescenti» 20 compresse;
A.I.C. n. 017076124 - «1000 mg compresse effervescenti» 30 compresse. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Glaxosmithkline Consumer Healthcare S.p.A. (codice fiscale 00867200156) con sede legale e domicilio fiscale in via Zambeletti snc - 20021 Baranzate - Milano (Italia). 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. 2. 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...
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