COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale veterinario «Synulox Endomammario» sospensione intramammaria per bovine in lattazione. (12A12235)
Estratto provvedimento n. 828 del 25 ottobre 2012
Medicinale veterinario, «SYNULOX ENDOMAMMARIO» sospensione intramammaria per bovine in lattazione.
Confezioni: confezione da 12 siringhe - A.I.C. n. 102475011.
Titolare A.I.C: Pfizer Italia S.r.l. con sede legale in Via Isonzo n. 71 - 04100 Latina, codice fiscale n. 06954380157.
Oggetto: Variazione Consequenziale: C.I.1 a. Modifica del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo secondo una procedura conforme agli articoli 30 o 31 della direttiva 2001/83/CE od agli articoli 34 o 35 della direttiva 2001/82/CE (procedura di rinvio): il medicinale rientra nel campo d'applicazione definito per il ricorso.
Sono autorizzate, per il medicinale veterinario indicato in oggetto, le modifiche dell'SPC e foglietto illustrativo/etichetta a seguito del Referral per conformare gli stampati a tutti gli Stati membri. In particolare:
Eccipienti
sono inseriti: Olio minerale (in formula A), Formula A: Cera emulsionante, Paraffina morbida bianca, Paraffina liquida leggera.
Posologia e via di somministrazione: viene inserito: somministrare per 3 mungiture consecutive.
Tempi di attesa: carne e visceri da: 4 a: 7 giorni.
Pertanto i tempi di attesa ora autorizzati sono:
Carne e...
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