COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tildren 5 mg/ml» polvere e solvente per soluzione iniettabile. (19A00409)
Estratto del provvedimento n. 943 del 28 dicembre 2018 Medicinale veterinario TILDREN 5 MG/ML polvere e solvente per soluzione iniettabile: scatola 1 flacone di 50 mg di acido tiludronico + 1 flacone con 10 ml di solvente - A.I.C. n. 103601011;
scatola 5 flaconi di 50 mg di acido tiludronico + 5 flaconi con 10 ml di solvente - A.I.C. n. 103601023;
scatola 10 flaconi di 50 mg di acido tiludronico + 10 flaconi con 10 ml di solvente - A.I.C. n. 103601035. Titolare A.I.C.: Audevard 42-46 rue Mederic - 92110 Clichy Francia. Oggetto del provvedimento: numero procedura europea: FR/V/0134/001/II/009. Variazione di tipo II, C.I.3 b Si autorizzano le modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglietto illustrativo del medicinale al fine di attuare le conclusioni di un procedimento concernente un rapporto periodico di aggiornamento sulla sicurezza, lo PSUR o uno studio sulla sicurezza dei medicinali dopo l'autorizzazione (PASS), o ancora le conclusioni della valutazione effettuata dall'autorita' competente a norma degli articoli 45 o 46 del regolamento (CE) n. 1901/2006 - b) attuazione di piu' modifiche che il titolare dell'autorizzazione all'immissione in commercio deve suffragare con nuove informazioni complementari. Per effetto della suddetta variazione gli stampati, devono essere modificati come segue: alla sezione «Precauzioni speciali per l'impiego-Precauzioni speciali per l'impiego negli animali» devono essere aggiunte le seguenti frasi: un accesso adeguato all'acqua potabile deve essere fornito durante l'utilizzo del prodotto. Laddove esistano dubbi circa la funzione renale, i parametri renali devono essere esaminati prima della somministrazione del prodotto. Il consumo di acqua e la produzione di urina devono essere monitorati dopo la somministrazione;
alla sezione «Reazioni avverse (frequenza e gravita')» devono essere aggiunte le seguenti frasi: nella fase di post-autorizzazione all'immissione in commercio del...
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