COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Starcef» (16A07886)
Estratto determina V&A n. 1572/2016 del 29 settembre 2016 E' autorizzata la seguente variazione: B.V.b.1.b) Aggiornamento del fascicolo qualita' destinato ad applicare le conclusioni di un procedimento di rinvio dell'Unione - L'armonizzazione del fascicolo qualita' non faceva parte del rinvio e l'aggiornamento ha lo scopo di armonizzarlo, relativamente al medicinale «STARCEF», nelle forme e confezioni A.I.C. n. 025859012 - «250 mg/1 ml polvere e solvente per soluzione iniettabile» 1 flacone polvere da 250 mg + fiala solvente 1 ml, A.I.C. n. 025859024 - «500 mg/1,5 ml polvere e solvente per soluzione iniettabile» 1 flacone polvere da 500 mg + 1 fiala solvente 1,5 ml, A.I.C. n. 025859036 - «1 g/3 ml polvere e solvente per soluzione iniettabile» 1 flacone polvere da 1 g + 1 fiala solvente 3 ml: armonizzazione del modulo 3 e conseguente modifica dei paragrafi 2, 3, 4.4, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 8 e 9 del Riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo e delle etichette. Titolare A.I.C.: F.I.R.M.A. S.p.A. (codice fiscale 00394440481) con sede legale e domicilio fiscale in via di Scandicci, 37, 50143 - Firenze (FI) Italia. E' approvata, altresi', secondo la lista dei termini standard della Farmacopea Europea, la descrizione delle confezioni cosi' come di seguito indicato: A.I.C. n. 025859012 da: «250 mg/1 ml polvere e solvente per soluzione iniettabile» 1 flacone polvere da 250 mg + fiala solvente 1 ml;
a: «250 mg/1 ml polvere e solvente per soluzione iniettabile» 1 flaconcino polvere + 1 fiala solvente da 1 ml;
A.I.C. n. 025859024 da: «500 mg/1,5 ml polvere e solvente per soluzione iniettabile» 1 flacone polvere da 500 mg + 1 fiala solvente 1,5 ml;
a: «500 mg/1,5 ml polvere e solvente per soluzione iniettabile» 1 flaconcino polvere + 1 fiala solvente da 1,5 ml;
A.I.C. n. 025859036 da: «1 g/3 ml polvere e solvente per soluzione iniettabile» 1 flacone polvere da 1 g + 1 fiala solvente 3 ml;
a: «1 g/3 ml polvere e solvente per soluzione iniettabile» 1 flaconcino polvere + 1 fiala solvente da 3 ml. Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come precedentemente autorizzati da questa amministrazione...
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