COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso veterinario «Sedastop 5 mg/ml» (11A10382)
Decreto n. 70 del 15 giugno 2011
Procedura decentrata n. NLN/0139/001/DC
Procedura decentrata n. NL/V/0139/001/IB/003/G.
Procedura decentrata n. NL/V/0139/001/IA/001
Specialita' medicinale per uso veterinario SEDASTOP 5 mg/ml soluzione iniettabile per cani e gatti.
Titolare A.I.C.: Le Vet B.V. con sede in Wilgenweg 7, 3421 TV Oudewater - Paesi Bassi.
Produttore responsabile rilascio lotti: Produlab Pharma B.V., nello stabilimento sito in Forellenweg 16, 4941 SJ, Raamsdonksveer - Paesi Bassi.
Confezioni autorizzate e numeri di a.I.C.:
Scatola di cartone con 1 flaconcino da 10 ml - A.I.C. n. 104183013
Scatola di cartone con 5 flaconcini da 10 ml - A.I.C. n. 104183025
Scatola di cartone con 10 flaconcini da 10 ml - A.I.C. n. 104183037
Composizione: 1 ml di soluzione iniettabile contiene:
Principio attivo:
Atipamezolo cloridrato 5,0 mg (equivalenti a 4,27 mg di atipamezolo)
Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti.
Specie di destinazione: Cani e gatti.
Indicazioni terapeutiche: L'atipamezolo cloridrato e' un a2-antagonista selettivo ed e' indicato per...
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