COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Fastumdol Antinfiammatorio». (19A04304)
Estratto determina AAM/PPA n. 482 del 17 giugno 2019 Si autorizza la seguente variazione, Tipo II, B.II.a.3b)2: modifica nella composizione degli eccipienti del prodotto finito della formulazione «25 mg granulato per sospensione orale», con conseguenti modifiche puntiformi ai par. 2 e 6.1 del RCP e corrispondenti sezioni del FI, relativamente al medicinale FASTUMDOL ANTINFIAMMATORIO, nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale: A.I.C. n.: 034041196 - «25 mg granulato per soluzione orale» 2 bustine Al/Pe monodose 034041208 - «25 mg granulato per soluzione orale» 4 bustine Al/Pe monodose 034041210 - «25 mg granulato per soluzione orale» 10 bustine Al/Pe monodose 034041222 - «25 mg granulato per soluzione orale» 20 bustine Al/Pe monodose 034041234 - «25 mg granulato per soluzione orale» 30 bustine Al/Pe monodose 034041246 - «25 mg granulato per soluzione orale» 40 bustine Al/Pe monodose 034041259 - «25 mg granulato per soluzione...
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