COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Eutirox» (15A01388)
Estratto determina V&A n° 257 del 16 febbraio 2015 Autorizzazione delle variazioni: Variazione di tipo II: C.I.4) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, e la Variazione di tipo IB, relativamente al medicinale EUTIROX;
E' autorizzato l'aggiornamento del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e delle etichette, relativamente al medicinale EUTIROX, nelle forme e confezioni sottoelencate: AIC N. 024402048 - "25 microgrammi compresse" 50 compresse AIC N. 024402051 - "75 microgrammi compresse" 50 compresse AIC N. 024402063 - "125 microgrammi compresse" 50 compresse AIC N. 024402075 - "150 microgrammi compresse" 50 compresse AIC N. 024402125 - "50 microgrammi compresse" 50 compresse AIC N. 024402137 - "100 microgrammi compresse" 50 compresse AIC N. 024402149 - "175 microgrammi compresse" 50 compresse AIC N. 024402152 - "200 microgrammi compresse" 50 compresse AIC N. 024402164 - "88 microgrammi compresse" 50 compresse AIC N. 024402176 - "112 microgrammi compresse" 50 compresse AIC N. 024402188 - "137 microgrammi compresse" 50 compresse Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: Merck Serono S.P.A. (codice fiscale 00399800580) con sede legale e domicilio fiscale in via Casilina, 125, 00176 - Roma (RM) 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...
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