COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio dei medicinali per uso veterinario «Guardian» - «Guardian Sr iniettabile» e «Duvaxyn Ie-T Plus». (11A02363)
Estratto decreto n. 10 del 26 gennaio 2011
La titolarita' dell'autorizzazione all'immissione in commercio delle specialita' medicinali per uso veterinario sotto elencate, fino ad ora registrate a nome della societa' Fort Dodge Animal Health S.p.a., con sede legale e fiscale in Aprilia (Latina), via Nettunense n. 90 - codice fiscale n. 00278930490:
GUARDIAN:
6 compresse da 30 mcg - A.I.C. n. 102568019;
6 compresse da 68 mcg - A.I.C. n. 102568021;
6 compresse da 136 mcg - A.I.C. n. 102568033;
GUARDIAN SR INIETTABILE:
1 flacone moxidectin microsfere + 1 flacone di veicolo - A.I.C. n. 103186019;
DUVAXYN IE-T PLUS:
1 siringa preriempita da 1 dose - A.I.C. n. 101472037;
10 flaconcini monodose - A.I.C. n. 101472049;
2 flaconcini monodose - A.I.C. n. 101472052, e' ora trasferita alla societa' Eli Lilly Italia S.p.a., con sede legale e amministrativa in Sesto Fiorentino (Firenze), via Gramsci n. 731-733, codice fiscale n. 00426150488.
La produzione ed il rilascio dei lotti continuano ad essere effettuati come in precedenza autorizzato:
Guardian
- produzione: officina farmaceutica Boehringer Ingelheim Vetmedica Inc, 141 East Riverside Drive, Iowa 50501 (USA), rilascio lotti: officina farmaceutica Fort Dodge Veterinaria S.A., Carretera Camprodon s.n. La Riba, Vall de Bianya, Olot, Girona (Spagna);
Guardian SR iniettabile
- produzione (formulazione microsfere): officina farmaceutica Boehringer Ingelheim Vetmedica...
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