COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Soludox» 500 mg/g. (12A08809)
Provvedimento n. 578 del 19 luglio 2012
Procedura mutuo riconoscimento n. NL/V/0141/001/1A/001
Specialita' medicinale per uso veterinario «SOLUDOX» 500 mg/g polvere da somministrare nell'acqua da bere per polli, nelle confezioni:
confezione da 10x100 g in polietilene - A.I.C. n. 104203017;
confezione da 1000 g in polietilene - A.I.C. n. 104203029;
confezione da 10x100 g in surlyn - A.I.C. n. 104203031;
confezione da 1000 g in surlyn - A.I.C. n. 104203043.
Oggetto: estensione d'uso alle specie suini e conseguente modifica dei stampati.
Titolare A.I.C.: Eurovet Animal Health B.V. con sede in Handelsweg 25, 5531 AE Bladel - Olanda.
E' autorizzata, a seguito della decisione della Commissione Europea del 14 luglio 2011 riguardante, nel quadro dell'art. 34 della direttiva 2001/82/CE del Parlamento Europeo e del Consiglio, l'autorizzazione all'immissione in commercio dei medicinali veterinari «Doxifar» 50% e denominazioni associate, l'estensione d'uso alla specie suini del medicinale veterinario indicato in oggetto.
Pertanto, le modifiche apportate agli stampati della specialita' medicinale per uso veterinario suindicata sono le seguenti:
Specie di destinazione: suini e polli (broiler, pollastre, galline da riproduzione).
Indicazioni terapeutiche:
suino: per il trattamento dei segni clinici associati alle malattie respiratorie nei suini, causate da Actinobacillus pleuropneumoniae, Pasteurella multocida e Mycoplasma hyopneumoniae sensibili alla doxiciclina;
pollo: laddove la malattia clinicamente manifesta e' presente nell'allevamento, per diminuire mortalita', morbilita' e...
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