COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso veterinario ad azione immunologica «Parvokan» (09A06257)
Decreto n. 56 del 6 maggio 2009
Procedura mutuo riconoscimento n. FR/V/0144/001/E001.
Specialita' medicinale per uso veterinario ad azione immunologica PARVOKAN.
Titolare A.I.C.: societa' Merial Italia S.p.A. con sede legale e domicilio fiscale in Milano - via Vittor Pisani n. 16 - codice fiscale n. 00221300288.
Produttore responsabile rilascio lotti: Merial Laboratoire Porte des Alpes nello stabilimento sito in 99, rue de l'Aviation - 69800 Saint priest (Francia).
Confezioni autorizzate e numeri di A.I.C.:
scatola con 1 flacone da 500 dosi di sospensione e 1 flacone da 500 dosi di liofilizzato - A.I.C. n. 104060013;
scatola con 1 flacone da 1500 dosi di sospensione e 3 flaconi da 500 dosi di liofilizzato - A.I.C. n. 104060025;
scatola con 10 flaconi da 500 dosi di sospensione e 10 flaconi da 500 dosi di liofilizzato - A.I.C. n. 104060037;
scatola con 10 flaconi da 1500 dosi di sospensione e 30 flaconi da 500 dosi di liofilizzato - A.I.C. n. 104060049.
Composizione: ogni dose da 0,2 ml di vaccino contiene:
Sospensione:
Principi attivi:
Virus inattivato della parvovirosi dell'anatra di Barberia;
Ceppo GM >= 1,5 log10 USN (*).
Adiuvante ed eccipienti: cosi' come indicati nella tecnica farmaceutica acquisita agli atti.
Liofilizzato:
Principi attivi:
Virus vivo attenuato della malattia di Derzsy, ceppo H >= 2,5 log DIT50.
(*) 1 USN: quanto basta...
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