COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso veterinario ad azione immunologica «Canigen Pi/L, liofilizzato e sospensione per sospensione iniettabile per cani», «Canigen L, sospensione iniettabile per cani», «Canigen DHPPi/L, liofilizzato e sospensione per sospensione iniettabile per cani». (18A06783)
Estratto provvedimento n. 686 del 27 settembre 2018 Medicinali veterinari ad azione immunologica: CANIGEN Pi/L, liofilizzato e sospensione per sospensione iniettabile per cani - A.I.C. n. 105018 - confezioni: tutte. CANIGEN L, sospensione iniettabile per cani - A.I.C. n. 105016 - confezioni: tutte. CANIGEN DHPPi/L, liofilizzato e sospensione per sospensione iniettabile per cani - A.I.C. n. 104931 - confezioni: tutte. Titolare A.I.C: Virbac 1ere avenue 2065 m LID 06516 Carros (Francia). Oggetto del provvedimento: procedura europea: FR/V/xxxx/WS/029. Variazione di tipo II, B.II.d.2.c. Si autorizza la modifica come di seguito descritta: sostituzione degli attuali test di potenza dei batch in vivo con saggi in vitro di quantificazione dell'antigene basato sul metodo ELISA per la rilevazione lipopolisaccaride (LPS). Per effetto della suddetta modifica si modificano i seguenti punti degli RCP: «Canigen L». 2. Composizione qualitativa e quantitativa. Ogni dose da 1 ml contiene: principi attivi: sospensione: Leptospira interrogans inattivata: sierogruppo Canicola sierotipo Canicola, ceppo 601903 - 4350 - 7330 U*;
sierogruppo Icterohaemorrhagiae sierotipo Icterohaemorrhagiae, ceppo 601895 - 4250 - 6910 U*;
*Unita' ELISA di massa antigenica;
eccipienti: per l'elenco completo degli eccipienti, vedere paragrafo 6.1. «Canigen Pi/L». 2. Composizione qualitativa e quantitativa. Ogni dose da 1 ml contiene: principi attivi: liofilizzato: virus della parainfluenza del cane (CPiV) - ceppo Manhattan 104.8 - 106.9 DICC50 * *dose infettante 50% della coltura cellulare;
sospensione: Leptospira interrogans inattivata: sierogruppo Canicola sierotipo Canicola, ceppo 601903 - 4350 - 7330 U**;
sierogruppo Icterohaemorrhagiae sierotipo Icterohaemorrhagiae, ceppo 601895 - 4250 -...
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