COMUNICATO - Autorizzazione all'immissione in commercio dei medicinali per uso veterinario «Milbactor 2,5 mg + 25 mg» e «Milbactor 12,5 mg + 125 mg». (15A03801)
Decreto n. 63 del 28 aprile 2015 Procedura decentrata n.. UK/V/0530/001-002/DC. Medicinale veterinario «MILBACTOR 2,5 mg+25 mg» compresse per cani di piccola taglia e cuccioli di peso corporeo di almeno 0,5 kg e, «Milbactor 12,5 mg+125 mg» per cani di peso corporeo di almeno 5 kg. Titolare A.I.C.: KRKA, d.d. Novo Mesto con sede in Šmarješka cesta 6, 8501 Novo mesto (Slovenia). Produttore responsabile rilascio lotti: la societa' titolare dell'A.I.C. nello stabilimento sito in Šmarješka cesta 6, 8501 Novo mesto (Slovenia). Confezioni autorizzate e numeri di A.I.C.: Milbactor 2,5 mg+25 mg compresse per cani di piccola taglia e cuccioli di peso corporeo di almeno 0,5 kg: Scatola contenente 4 compresse - A.I.C. n. 104724012;
Scatola contenente 48 compresse - A.I.C. n. 104724024. Milbactor 12,5 mg+125 mg compresse per cani di peso corporeo di almeno 5 kg: Scatola contenente 4 compresse - A.I.C. n. 104724036;
Scatola contenente 48 compresse - A.I.C. n. 104724048. Composizione: Milbactor 2,5 mg+25 mg compresse per cani di piccola taglia e cuccioli di peso corporeo di almeno 0,5 kg: Una compressa contiene: principio attivo: Milbemicina ossima 2,5 mg;
Praziquantel 25,0 mg. Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Milbactor 12,5 mg+125 mg compresse per cani di peso corporeo di almeno 5 kg: Una compressa contiene: Principio attivo: Milbemicina ossima 12,5 mg;
Praziquantel 125,0 mg. Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Specie di destinazione: Milbactor 2,5 mg+25 mg: Cani (piccola taglia e cuccioli). Milbactor 12,5 mg+125 mg: Cani (che pesano almeno 5 kg). Indicazioni terapeutiche: Nei cani: trattamento di...
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