COMUNICATO - Modificazioni dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario ad azione immunologica «Nobilis REO+IB+G+ND».
Estratto provvedimento n. 16 del 4 febbraio 2008
Specialita' medicinale per uso veterinario ad azione immunologica NOBILIS REO+IB+G+ND, nelle confezioni:
1 flacone da 100 dosi (500 ml) - A.I.C. n. 101925016.
Titolare A.I.C.: Intervet international B.V. sito in Boxmeer (Olanda), rappresentata in Italia dalla societa' Intervet Italia S.r.l., con sede legale e domicilio fiscale in Peschiera Borromeo (Milano) - Via W. Tobagi n. 7 - codice fiscale n. 01148870155.
Variazione tipo II: aggiunta di un sito alternativo per il controllo qualita' del prodotto finito.
E' autorizzata la variazione tipo II della specialita' medicinale per uso veterinario ad azione immunologica indicata in oggetto concernente l'aggiunta del sito produttivo Laboratorios Intervet S.A. - Salamanca (Spagna), responsabile del controllo qualita' sul prodotto finito per il test: controllo assenza contaminazione batterica e/o fungina (test di sterilita). Il sito precedentemente autorizzato per il controllo qualita' del prodotto finito e' Intervet International B.V. - Boxmeer (Olanda).
I lotti gia' prodotti possono rimanere in commercio fino alla data di scadenza posta in etichetta.
Decorrenza ed efficacia del provvedimento: dal giorno della sua pubblicazione nella Gazzetta Ufficiale della Repubblica italiana.
Estratto provvedimento n. 17 del 4 febbraio 2008
Specialita' medicinale per uso veterinario ad azione immunologica NOBILIS REO+IB+G+ND, nelle confezioni:
1 flacone da 100 dosi (500 ml) - A.I.C. n. 101925016.
Titolare A.I.C.: Intervet international B.V. sito in Boxmeer (Olanda), rappresentata in Italia dalla societa' Intervet Italia S.r.l., con sede legale e domicilio fiscale in Peschiera Borromeo (Milano) - Via W...
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