COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Benactiv gola» (16A08342)
Estratto determina AAM/PPA n. 1857 del 14 novembre 2016 Autorizzazione delle variazioni: 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 «Benactiv Gola»;
E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto, del foglio illustrativo e delle etichette, relativamente al medicinale BENACTIV GOLA, nelle forme e confezioni sottoelencate: AIC N. 033262015 - «2,5 mg/ml colluttorio» flacone 160 ml AIC N. 033262027 - «8,75 mg pastiglie gusto limone e miele» 16 pastiglie AIC N. 033262039 - «8,75 mg pastiglie gusto limone e miele» 24 pastiglie AIC N. 033262041 - «2,5 mg/ml spray per mucosa orale» flaconcino 15 ml AIC N. 033262078 - «8,75 mg pastiglie senza zucchero gusto arancia» 16 pastiglie AIC N. 033262080 - «8,75 mg pastiglie senza zucchero gusto arancia» 24 pastiglie E' inoltre autorizzata la rettifica dello Standard Terms della descrizione della confezione da: AIC N. 033262041 - «2,5 mg/ml spray per mucosa orale» flaconcino 15 ml a: AIC N. 033262041 - «2,5 mg/ml spray per mucosa orale» flacone 15 ml Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: Reckitt Benckiser Healthcare International Limited con sede legale e domicilio in 103-105 Bath Road, SL1 3UH - Slough Berkshire (Regno Unito) 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...
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