COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Sinertec». (16A08346)
Estratto determina AAM/PPA n. 1861 del 14 novembre 2016 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 le Variazioni di tipo IB, relativamente al medicinale SINERTEC. Numeri di procedura: DK/H/0110/001/II/042;
DK/H/0110/001/IB/038/G. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto e del foglio illustrativo, relativamente al medicinale «Sinertec», nella forma e confezione sotto-elencata: A.I.C. n. 033266014 - 14 compresse. E' inoltre autorizzata la rettifica dello Standard Terms della descrizione della confezione da: A.I.C. n. 033266014 - 14 compresse;
a: A.I.C. n. 033266014 - «20 mg/6 mg compresse» 14 compresse in blister a pressione in alluminio con laminato in PVC. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: MSD Italia S.r.l., con sede legale e domicilio fiscale in Roma (RM), via Vitorchiano n. 151, CAP 00189;
Italia;
codice fiscale n. 00422760587. 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 s.m.i., il foglio illustrativo e le etichette devono essere redatti...
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