COMUNICATO - Modificazione all''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Cevaflox» 100 mg/ml. (12A07319)
Provvedimento n. 447 del 8 giugno 2012
PROCEDURA MUTUO RICONOSCIMENTO N. FR/V/0185/001/IB/005/G
Specialita' medicinale per uso veterinario "CEVAFLOX" 100 mg/ml soluzione orale per polli e tacchini, nelle confezioni:
- Flacone da 100 ml - A.I.C. n. 104386014
- Flacone da 1 litro - A.I.C. n. 104386026
TITOLARE A.I.C.: CEVA SALUTE ANIMALE con sede legale e domicilio fiscale in Agrate Brianza (MB) - Viale Colleoni, 15 - codice fiscale n. 09032600158.
OGGETTO: Variazione tipo IB: riduzione del periodo di validita' del prodotto finito come confezionato per la vendita e modifica delle condizioni di conservazione limitatamente alla confezione flacone da 100 ml.
Modifica stampati.
Si autorizza, per la sola confezione flacone da 100 ml - A.I.C. n. 104386014 della specialita' medicinale per uso veterinario indicata in oggetto, la variazione tipo IB concernente la riduzione del periodo di validita' del prodotto finito come confezionato per la vendita da 24 mesi a 18 mesi e, inoltre, la modifica delle condizioni di conservazione del prodotto finito da "nessuna condizione di conservazione" a "conservare ad un temperatura inferiore ai 25°C".
Tali modifiche impattano sui seguenti punti del SPC e corrispondenti punti degli stampati illustrativi:
Punto 6.3 si modifica come di seguito:
Periodo di validita' del medicinale come confezionato per la vendita:
Flacone da 100 ml: 18 mesi
Flacone da 1000 ml: 24 mesi
Periodo di validita' dopo prima...
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