COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «Inmeva» sospensione iniettabile. (19A06360)
Estratto decreto n. 124 del 17 settembre 2019 Procedura decentrata n. FR/V/0350/001/DC. Medicinale veterinario ad azione immunologica INMEVA sospensione iniettabile. Titolare A.I.C.: Laboratorios Hipra, S.A. , con sede legale e domicilio fiscale, in via Avda. la Selva n. 135 - 17170 Amer (Girona) - Spagna. Produttore responsabile rilascio lotti: Laboratorios Hipra, S.A., Avda. la Selva n. 135 - 17170 Amer (Girona) - Spagna. Confezioni autorizzate e numeri di A.I.C.: scatola di cartone con 1 flacone da 5 dosi (10 ml) - A.I.C. n. 105259016;
scatola di cartone con 1 flacone da 25 dosi (50 ml) - A.I.C. n. 105259028;
scatola di cartone con 1 flacone da 50 dosi (100 ml) - A.I.C. n. 105259030;
scatola di cartone con 1 flacone da 125 dosi (250 ml) - A.I.C. n. 105259042. Composizione: ogni dose da 2 ml contiene: principi attivi: ceppo A22 di chlamydia abortus inattivato RP* ≥
1;
ceppo Sao di salmonella enterica subsp. enterica serovar abortusovis inattivato RP* ≥
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*Potenza relativa determinata mediante ELISA, utilizzando un vaccino di riferimento di efficacia dimostrata. Adiuvanti: idrossido di alluminio (alluminio) 5,29 mg;
DEAE destrano 20 mg. Eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti...
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