COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale veterinario «Trichopelen.IT». (14A03452)
Estratto provvedimento n. 328 dell'8 aprile 2014 Oggetto: Medicinale veterinario "TRICHOPELEN.IT Confezioni: 1-Astuccio da 10x1ml di sospensione, contenente 10 flaconi di liofilizzato della capacita' di 3 ml + 10 flaconi ciascuno da 1 ml di diluente A.I.C. n. 104518016 2-Astuccio da 100ml di sospensione, contenente 1 flacone di liofilizzato della capacita' di 10 ml + 1 flacone da 100 ml di diluente A.I.C. n. 104518030 3-Astuccio da 5x10ml di sospensione, contenente 5 flaconi di liofilizzato della capacita' di 10 ml + 5 flaconi ciascuno da 10 ml di diluente A.I.C. n. 104518042 Titolare: Alla Societa' SOLUZIONI VETERINARIE S.r.l. con sede in Vicolo Mazzini 4, 31050 Fontane di Villorba (TV), Italia Modifica: 1) VARIAZIONE di tipo IA: B.II.e.5.b Modifica nella dimensione della confezione del prodotto finito. Soppressione di una piu' dimensioni di confezione. 2) Variazione di tipo IA: B.II.e.5.a.1 Modifica nella dimensione della confezione del prodotto finito. Modifica del numero di unita' (compresse, fiale, ecc.) in una confezione. Modifica entro i limiti delle dimensioni di confezione al momento approvate. 3) Variazione di tipo IA: B.II.e.6.a Modifica di un elemento del materiale di confezionamento (primario) che non e' in contatto con la formulazione del prodotto finito [ad esempio colore del tappo amovibile, codice colore sugli anelli delle fiale, protezione dell'ago (utilizzo di una plastica diversa)]. Modifica che incide sulle informazioni relative al prodotto. 4) Variazione di tipo IA: A.6 Modifica del codice ATC o del codice ATC Vet. Si autorizzano le modifiche come di seguito descritte: 1) Soppressione della confezione di dimensioni 10x10ml di sospensione, A.I.C. n. 104518028, contenente 10 flaconi di liofilizzato della capacita' di 10 ml + 10 flaconi ciascuno da 10 ml di diluente (B.II.e.5.b). 2) Aggiunta...
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