COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso veterinario «Soludox 500 mg/g polvere da somministrazione nell''acqua da bere per polli.». (11A06807)
Decreto n. 44 del 26 aprile 2011
Procedura decentrata n. NL/V/0141/001/DC.
Specialita' medicinale per uso veterinario SOLUDOX 500 mg/g polvere da somministrare nell'acqua da bere per polli.
Titolare A.I.C.: Eurovet Animal Health B.V., con sede in Handelsweg 25, 5531 AE Bladel - Olanda.
Produttore responsabile rilascio lotti: la societa' titolare dell'A.I.C. nello stabilimento sito in Handelsweg 25, 5531 AE Bladel - Olanda.
Confezioni autorizzate e numeri di A.I.C.:
confezione da 10×100 g in polietilene - A.I.C. n. 104203017;
confezione da 1.000 g in polietilene - A.I.C. n. 104203029;
confezione da 10×100 g in surlyn - A.I.C. n. 104203031;
confezione da 1.000 g in surlyn - A.I.C. n. 104203043.
Composizione: 1 grammo di polvere contiene:
principio attivo: 500 mg di doxiciclina iclato, pari a 433 mg di doxiciclina;
eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti.
Specie di destinazione: polli (broiler, pollastre, galline da riproduzione).
Indicazioni terapeutiche: polli (broiler, pollastre, galline da riproduzione): ove la malattia clinica sia presente in allevamento, trattamento e prevenzione della pasteurellosi causata da Pasteurella multocida o infezioni respiratorie causate da Ornithobacterium rhinotracheale (ORT).
Validita':
periodo di validita' del medicinale veterinario confezionato per la vendita: 3 anni;
periodo di validita' dopo la prima...
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