COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tildosin 250 mg/ml soluzione per uso nell'acqua da bere o nel latte artificiale per bovini, suini, polli e tacchini.». (18A06222)
Estratto decreto n. 113 del 3 settembre 2018 Medicinale veterinario «TILDOSIN 250 mg/ml soluzione per uso nell'acqua da bere o nel latte artificiale per bovini, suini, polli e tacchini». Procedura decentrata n. UK/V/0607/001/DC. Titolare A.I.C.: Dopharma Research B.V., con sede legale e domicilio fiscale, in via Zalmweg 24, 4941 VX Raamsdonksveer, Paesi Bassi. Produttore responsabile rilascio lotti: Dopharma B.V., via Zalmweg 24, 4941 VX Raamsdonksveer, Paesi Bassi. Confezioni autorizzate e numeri di A.I.C.: flacone da 960 ml - A.I.C. n. 105096010;
flacone da 5040 ml - A.I.C. n. 105096022. Composizione: 1 ml contiene: Principio attivo: Tilmicosina (sotto forma di tilmicosina fosfato): 250 mg. Eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti. Indicazioni terapeutiche: Vitelli: trattamento e metafilassi della sindrome respiratoria bovina associata a Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis e M. dispar sensibili alla tilmicosina. Suini: trattamento e metafilassi della sindrome respiratoria associata a Mycoplasma hyopneumoniae, Pasteurella multocida e Actinobacillus pleuropneumoniae sensibili alla tilmicosina. Polli: trattamento e metafilassi della sindrome respiratoria associata a Mycoplasma gallisepticum e M. synoviae sensibili alla tilmicosina. Tacchini: trattamento e metafilassi della sindrome respiratoria...
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