COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario 'Duramune DAP+L'
Estratto decreto n. 52 del 17 ottobre 2007
Procedura decentrata n. UK/V/0007/001/DC.
Specialita' medicinale per uso veterinario ad azione immunologica DURAMUNE DAP+L.
Titolare A.I.C.: Fort Dodge Animal Health S.p.a., con sede legale e fiscale in Aprilia (Latina), via Nettunense, 90 - codice fiscale n. 00278930490.
Produttore: officina Fort Dodge Animal Health, con sede in Charles City, Iowa (USA), e officina Fort Dodge Laboratories Ireland, con sede in Sligo (Irlanda), Finiskilin Industrial Estate, responsabile anche del rilascio dei lotti.
Confezioni autorizzate e numeri di A.I.C.:
10 fiale da 1 dose + 10 fiale da 1 ml di solvente A.I.C. n. 103846010;
25 fiale da 1 dose + 25 fiale da 1 ml di solvente A.I.C. n. 103846022;
50 fiale da 1 dose + 50 fiale da 1 ml di solvente A.I.C. n. 103846034;
100 fiale da 1 dose + 100 fiale da 1 ml di solvente A.I.C. n. 103846046.
Composizione: per 1 ml dose:
frazione liofilizzata:
principi attivi: virus del cimurro del cane, ceppo onderstepoort 102.5 a 104.8 TCID50*, adenovirus canino tipo 2, ceppo V197 104.8 a 107.0 TCID50*, parvovirus canino, ceppo SAH 104.7 a 106.5* TCID50* (* TCID50 = 50% dose infettante in colture di tessuto);
eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti;
frazione liquida diluente:
principi attivi: leptospira interrogans bacterio inattivato (OMC) sierogruppo canicola, sierovariante canicola: potenza in accordo con F.E.*, sierogruppo icterohaemorrhagiae, sierovariante icterohaemorrhagiae potenza in accordo con...
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