COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «EquiShield EHV, emulsione iniettabile per cavalli». (19A03866)
Decreto n. 83 del 23 maggio 2019 Procedura di mutuo riconoscimento n. CZ/V/0153/001/MR Medicinale veterinario ad azione immunologica: EQUISHIELD EHV, emulsione iniettabile per cavalli. Titolare A.I.C.: la ditta Dechra Regulatory B.V. Handelsweg 25 - 5531 AE Bladel - Paesi Bassi. Produttore responsabile rilascio lotti: lo stabilimento Bioveta, a.s. - Komenskeho 212/12, 683 23 Ivanovice na Hane', Repubblica Ceca. Confezioni autorizzate e numeri di A.I.C.: scatola con 2 flaconcini contenenti una dose ciascuna - A.I.C. n. 105273015;
scatola con 5 flaconcini contenenti una dose ciascuna - A.I.C. n. 105273027;
scatola con 10 flaconcini contenenti una dose ciascuna - A.I.C. n. 105273039;
scatola con 1 flaconcino contenente 5 dosi - A.I.C. n. 105273041;
scatola con 10 flaconcini contenenti 5 dosi ciascuna - A.I.C. n. 105273054. Composizione: una dose di vaccino (1 ml) contiene: principio attivo: Herpesvirus di tipo 1 equino inattivato, (Bio 82: EHV-1) Min. 2,1 log10 VNI1 1 Indice di neutralizzazione virale determinato nel siero di criceti. Eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti. Indicazioni terapeutiche: per l'immunizzazione attiva dei cavalli al fine di ridurre i segni clinici e l'escrezione virale nel corso della malattia respiratoria causata da...
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