COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «Eurican DHPPi2 -Lmulti» Liofilizzato e sospensione per sospensione iniettabile. (16A02865)
Decreto n. 41 del 9 marzo 2016 Procedura decentrata n. FR/V/0286/001/DC. Medicinale veterinario ad azione immunologica Eurican DHPPi2 -Lmulti Liofilizzato e sospensione per sospensione iniettabile. Titolare A.I.C.: La societa' Merial Italia S.p.A. con sede in Via Vittor Pisani, 16 - 20124 Milano - Codice Fiscale 00221300288. Produttore responsabile rilascio lotti: Lo stabilimento Merial Laboratoire Porte des Alpes, Rue de l'Aviation 69800 - Saint-Priest - Francia. Confezioni autorizzate e numeri di A.I.C.: 10 flaconi da 1 dose di vaccino liofilizzato e 10 flaconi da 1 ml di solvente - A.I.C. n. 104861012;
25 flaconi da 1 dose di vaccino liofilizzato e 25 flaconi da 1 ml di solvente - A.I.C. n. 104861024;
50 flaconi da 1 dose di vaccino liofilizzato e 50 flaconi da 1 ml di solvente - A.I.C. n. 104861036. Composizione: Una dose di liofilizzato contiene: Parte di provvedimento in formato grafico Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Una dose di sospensione contiene: Principi attivi: Leptospira interrogans inattivata, sierogruppo e sierovariante Canicola ceppo 16070 - Attivita' secondo Farm. Eur. 447* Leptospira interrogans inattivata, sierogruppo e sierovariante Icterohaemorrhagiae ceppo 16069 - Attivita' secondo Farm. Eur. 447* Leptospira interrogans inattivata, sierogruppo e sierovariante Grippotyphosa ceppo Grippo Mal 1540 - Attivita' secondo Farm. Eur. 447* *≥80% protezione nel criceto Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Specie di destinazione: Cani. Indicazioni terapeutiche: Immunizzazione attiva dei cani per: prevenire la mortalita' ed i segni clinici causati dal virus del Cimurro, prevenire la mortalita' ed i segni clinici causati dal virus dell'epatite canina infettiva, ridurre l'escrezione virale nel corso della malattia respiratoria causata dall'adenovirus canino di tipo 2, prevenire la mortalita', i segni clinici e l'escrezione virale causati dal parvovirus canino, ridurre l'escrezione virale causata dal virus della...
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