COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso veterinario «Florfenikel» 300 mg/ml (12A10761)
Estratto decreto n. 118 del 6 settembre 2012
Procedura decentrata n. UK/V/0379/001/DC.
Specialita' medicinale per uso veterinario "FLORFENIKEL" 300 mg/ml soluzione per iniezione per suini.
Titolare A.I.C.: societa' Kela N.V. con sede in St. Lenaartseweg 48, 2320 Hoogstraten, Belgio.
Produttore responsabile rilascio lotti:
flacone di vetro: Kela N.V. nello stabilimento sito in St. Lenaartseweg 48, 2320 Hoogstraten, Belgio;
flacone di polipropilene: SP Veterinaria nello stabilimento sito in Ctrza. Reus-Vinyols km 4.1, Aptdo.60 - 43330 Riudoms (Spagna).
Confezioni autorizzate e numeri di A.I.C.:
flacone in vetro da 100 ml - A.I.C. n. 104334014;
flacone in vetro da 250 ml - A.I.C. n. 104334026;
flacone in polipropilene da 100 ml - A.I.C. n. 104334038;
flacone in polipropilene da 250 ml - A.I.C. n. 104334040.
Composizione: ogni ml contiene:
principio attivo: florfenicolo 300 mg;
eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti.
Specie di destinazione: suini
Indicazioni terapeutiche: suini: trattamento di episodi acuti di malattia respiratoria provocata da ceppi...
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