COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Tilclor». (12A11450)
Estratto provvedimento n. 770 del 2 ottobre 2012
Medicinale veterinario TILCLOR polvere per uso orale per vitelli da latte, nelle confezioni:
barattolo da 1 kg - A.I.C. n. 102699016;
sacchetto da 250 g - A.I.C. n. 102699028;
sacco da 1 kg - A.I.C. n. 102699030;
sacco da 5 kg - A.I.C. n. 102699042.
Titolare A.I.C.: Ceva Salute Animale S.p.A. con sede legale e domicilio fiscale in Agrate Brianza (MB), viale Colleoni, 15 - codice fiscale n. 09032600158.
Oggetto del provvedimento:
variazione tipo IB B.II.a.3b6: modifiche nella composizione (eccipienti) del prodotto finito, altri eccipienti: sostituzione di un solo eccipiente con un eccipiente comparabile avente le stesse caratteristiche funzionali e a livello simile;
variazione tipo IB foreseen - B.II.a.3 b1 - Modifica nella composizione quali-quantitativa del prodotto finito: aggiunta di eccipienti;
variazione tipo IA: B.II.f1 a2 - Modifica della durata di conservazione o delle condizioni di magazzinaggio del prodotto finito: riduzione della durata di conservazione del prodotto finito dopo la prima apertura.
Si autorizzano, per il medicinale veterinario indicato in oggetto le seguenti variazioni nella composizione quali-quantitativa (eccipienti), e, precisamente:
variazione tipo IB B.II.a.3b6 concernente la sostituzione dell'eccipiente destrosio monoidrato con l'eccipiente maltodestrina, con le stesse caratteristiche funzionali;
variazione tipo IB foreseen - B.II.a.3 b1 concernente l'aggiunta dell'eccipiente polisorbato 80 come adeguamento minore nella composizione del prodotto finito.
Pertanto, la composizione ora autorizzata e' la seguente:
principi attivi: invariati;
eccipienti: cosi' come...
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