COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Prascend 1 mg». (12A00549)
Provvedimento n. 314 del 22 dicembre 2011
Procedura decentrata n. DE/V/0130/001/II/005/G.
Medicinale per uso veterinario PRASCEND 1 mg compresse per cavalli non destinati alla produzione di alimenti per il consumo umano.
Confezioni:
60 compresse - A.I.C. n. 104134022;
100 compresse - A.I.C. n. 104134010;
160 compresse - A.I.C. n. 104134034.
Titolare A.I.C.: Boehringer Ingelheim Vetmedica GmbH - Binger Strasse 173 - 55216 Ingelheim am Rhein (Germania) rappresentata in Italia dalla societa' Boehringer Ingelheim Italia S.p.a. con sede in Loc. Prulli n. 103/c - 50066 Reggello (Firenze) Cod. fisc. 00421210485.
Oggetto del provvedimento:
Variazione tipo II: Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza - variazione relativa alla sicurezza.
Variazione tipo II: Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza - variazione relativa all'efficacia.
Variazione tipo IB non prevista relativa a modifiche editoriali dei testi.
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