COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Sinestic». (17A04948)
Estratto determina AAM/PPA n. 692 del 26 giugno 2017 Autorizzazione della variazione: 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 SINESTIC. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto alle sezioni 4.1, 4.2, 4.5 e 5.1 e corrispondenti paragrafi del foglio illustrativo, relativamente al medicinale Sinestic, nelle forme e confezioni sottoelencate: A.I.C. n. 035260013 - «Turbohaler» 1 inalatore 60 dosi 160/4.5 mcg;
A.I.C. n. 035260025 - «Turbohaler» 10 inalatori 60 dosi 160/4.5 mcg;
A.I.C. n. 035260037 - «Turbohaler» 3 inalatori 60 dosi 160/4.5 mcg;
A.I.C. n. 035260049 - «Turbohaler» 2 inalatori 60 dosi 160/4.5 mcg;
A.I.C. n. 035260052 - «Turbohaler» 18 inalatori 60 dosi 160/4.5 mcg;
A.I.C. n. 035260064 - «Turbohaler» 1 inalatore 120 dosi 160/4.5 mcg;
A.I.C. n. 035260076 - «Turbohaler» 3 inalatori 120 dosi 160/4.5 mcg;
A.I.C. n. 035260088 - «Turbohaler» 2 inalatori 120 dosi 160/4.5 mcg;
A.I.C. n. 035260090 - «Turbohaler» 10 inalatori 120 dosi 160/4.5 mcg;
A.I.C. n. 035260102 - «Turbohaler» 18 inalatori 120 dosi 160/4.5 mcg. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Astrazeneca S.p.a. (codice fiscale n. 00735390155) con sede legale e domicilio fiscale in Palazzo Ferraris, via Ludovico il Moro n. 6/C, 20080 - Basiglio - Milano (MI) 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...
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