COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «Unistrain» PRRS liofilizzato e solvente per sospensione iniettabile per suini. (13A02795)
Decreto n. 26 del 8 marzo 2013 Procedura decentrata n. IE/V/0287/001/DC. Medicinale veterinario «UNISTRAIN» PRRS Liofilizzato e solvente per sospensione iniettabile per suini. Titolare A.I.C.: Laboratorios Hipra, S.A. con sede in Avda. La Selva, 135 - 17170 Amer, Girona (Spagna) rappresentata in Italia dalla societa' HIPRA ITALIA S.r.l. con sede in via Franciacorta, 74 - 25038, Rovato (Brescia) Italia. Produttore responsabile rilascio lotti: la societa' titolare dell'A.I.C con sede in Avda. La Selva, 135 - 17170 Amer, Girona (Spagna). Confezioni autorizzate e numeri di A.I.C.: 1 flacone da 10 dosi di liofilizzato e 1 flacone con 20 ml di solvente - A.I.C. n. 104476015;
1 flacone da 25 dosi di liofilizzato e 1 flacone con 50 ml di solvente - A.I.C. n. 104476027;
1 flacone da 50 dosi di liofilizzato e 1 flacone con 100 ml di solvente - A.I.C. n. 104476039;
10 flaconi con 10 dosi di liofilizzato - A.I.C. n. 104476041;
10 flaconi con 20 ml di solvente - A.I.C. n. 104476054;
10 flaconi con 25 dosi di liofilizzato - A.I.C. n. 104476066;
10 flaconi con 50 dosi di liofilizzato - A.I.C. n. 104476078;
10 flaconi con 50 ml di solvente - A.I.C. n. 104476080;
10 flaconi con 100 ml di solvente - A.I.C. n. 104476092. Composizione: ogni flaconcino di liofilizzato contiene: Principio attivo: Virus della sindrome riproduttiva e respiratoria del suino (PRRSV, Porcine reproductive and respiratory virus) vivo e attenuato, ceppo VP-046 BIS.....................10 3,5 -105,5 DICC50 Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Solvente: composizione per dose da 2 ml. Soluzione tampone fosfato. Eccipienti: cosi' come indicato nella...
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