COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Vanguard CPV». (12A09484)
Provvedimento n. 604 del 27 luglio 2012
Specialita' medicinale per uso veterinario ad azione immunologica VANGUARD CPV vaccino vivo attenuato per cani, nelle confezioni:
Confezioni:
1 flacone da 1 dose - A.I.C. n. 100314018;
10 flaconi da 1 dose - A.I.C. n. 100314020;
25 flaconi da 1 dose - A.I.C. n. 100314032.
Titolare A.I.C.: Pfizer Italia S.r.l. con sede legale e domicilio fiscale in Latina - via Isonzo n. 71 - codice fiscale n. 06954380157.
Oggetto:
variazione tipo II: modifica del paragrafo 4.2 del riassunto delle caratteristiche del prodotto relativa all'inizio immunita' per la componente parvovirosi;
variazione tipo II: modifica del paragrafo 4.2 del riassunto delle caratteristiche del prodotto relativa alle indicazioni per la componente parvovirosi.
Si autorizzano, per il medicinale veterinario indicato in oggetto, le variazioni tipo II concernenti la modifica del punto 4.2 del riassunto delle caratteristiche del prodotto e relativo punto 4 del foglietto illustrativo (immunita' e indicazioni della parvovirosi del cane).
Pertanto le indicazioni della specialita' medicinale per uso veterinario ad azione immunologica suindicata ora autorizzate sono le seguenti:
Indicazioni terapeutiche: il vaccino e' indicato per l'immunizzazione attiva di cani sani nei confronti dell'infezione da parvovirus canino. Il vaccino previene la mortalita', la sintomatologia clinica, inclusa la leucopenia e riduce la...
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