COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio di taluni medicinali per uso veterinario (10A09407)
Estratto provvedimento n. 147 del 27 luglio 2010
Titolare A.I.C.: Sintofarm S.p.A., con sede legale e domicilio fiscale in Guastalla (Reggio-Emilia) via Togliatti, 5 - codice fiscale n. 00273680355.
Oggetto:
variazione tipo IB: sostituzione o aggiunta di un sito di fabbricazione per una parte o per la totalita' del procedimento di fabbricazione del prodotto finito: sito in cui sono effettuate tutte le operazioni, ad eccezione della liberazione dei lotti, del controllo dei lotti e dell'imballaggio secondario per i medicinali non sterili;
variazione consequenziale di tipo IA: sostituzione del sito responsabile del rilascio, compreso il controllo, dei lotti del prodotto finito.
Si autorizza, per le confezioni delle specialita' medicinali per uso veterinario di seguito elencate:
SINTOMUTYLIN 100, nella confezione: sacco da 25 kg - A.I.C. n. 102643018;
TIAMULINA 45% SINTOFARM, nelle confezioni: fustino da 5 kg - A.I.C. n. 102644010 e fustino da 1 kg - A.I.C. n. 102644022;
OSSITETRACICLINA 20% SINTOFARM, nelle confezioni: sacco da 2 kg - A.I.C. n. 102642016 e sacco da 5 kg - A.I.C...
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