COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Klacid». (15A02811)
Estratto determina V&A n. 610 del 1° aprile 2015 Autorizzazione della variazione: 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, relativamente al medicinale KLACID;
E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto, del foglio illustrativo e delle etichette, relativamente al medicinale KLACID, nelle forme e confezioni sottoelencate: A.I.C. n. 027370042 - «500 mg/10 ml polvere e solvente per soluzione per infusione» 1 flaconcino polvere +1 fiala solvente 10 ml;
A.I.C. n. 027370055 - «250 mg compresse rivestite» 12 compresse;
A.I.C. n. 027370067 - «125 mg/5 ml granulato per sospensione orale» 1 flacone da 100 ml;
A.I.C. n. 027370093 - «250 mg granulato per sospensione orale» 14 bustine;
A.I.C. n. 027370105 - «500 mg granulato per sospensione orale» 14 bustine;
A.I.C. n. 027370117 - «250 mg/5 ml granulato per sospensione orale» 1 flacone da 100 ml;
A.I.C. n. 027370129 - «500 mg compresse rivestite» 14 compresse;
A.I.C. n. 027370143 - «RM 500 mg compresse a rilascio modificato» 7 compresse. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Abbott S.R.L. (codice fiscale 00076670595) con sede legale e domicilio fiscale in S.R. 148 Pontina KM 52 SNC - Campoverde di Aprilia, 04011 - Latina (LT) 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 e all'etichettatura. 2. In ottemperanza all'art. 80, commi 1 e...
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