Modificazione dell'autorizzazione all'immissione in commercio di alcune confezioni della specialita' medicinale per uso veterinario .
Provvedimento n. 72 del 27 aprile 2006
Specialita' medicinale per uso veterinario: TERRAMICINA LONG ACTING.
Confezioni:
flacone da 50 ml - A.I.C. n. 100088018;
flacone da 100 ml - A.I.C. n. 100088020;
flacone da 250 ml - A.I.C. n. 100088032;
flacone da 500 ml - A.I.C. n. 100088044.
Titolare A.I.C.: Pfizer Italia S.r.l. con sede legale in Borgo San Michele (Latina) s.s. 156 km 50 - codice fiscale 06954380157.
Oggetto del provvedimento: variazione tipo II - aggiunta stio produzione.
Si autorizza l'aggiunta del seguente sito per la produzione per il prodotto finito: Laboratorio Pfizer Ltda. - Av. Monteiro Lobato 2270 - Guarulhos - SP (Brasile). Le operazioni di controllo dei lotti in Europa saranno effettuate dall'officina Pfizer PGM - Amboise - Poce' sur Cisse (Francia).
Il presente provvedimento entra in vigore dal giorno della sua pubblicazione nella Gazzetta Ufficiale della Repubblica italiana.
Provvedimento n. 73 del 27 aprile 2006
Specialita' medicinale per uso veterinario: TERRAMICINA LONG ACTING nelle confezioni:
flacone da 50 ml - A.I.C. n. 100088018;
flacone da 100 ml - A.I.C. n. 100088020;
flacone da 250 ml - A.I.C. n. 100088032;
flacone da 500 ml - A.I.C. n. 100088044.
Titolare A.I.C.: Pfizer Italia S.r.l. con sede legale in Borgo San Michele...
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