COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso veterinario «Equest gel orale» 18,92 mg/g gel orale per cavalli e ponies e «Equest Pramox» 19,5 mg/g + 121,7 mg/g gel orale. (18A01213)
Estratto provvedimento n. 43 del 22 gennaio 2018 Medicinali veterinari: Equest gel orale 18,92 mg/g gel orale per cavalli e ponies (A.I.C. n. 102720) - procedura n. FR/V/0020/002/IA/027/G;
Equest Pramox 19,5 mg/g + 121,7 mg/g gel orale (A.I.C. n. 103820) - procedura n. FR/V/0161/001/IA/024/G. Titolare A.I.C.: Zoetis Italia S.r.l. via Andrea Doria, 41 M - 00192 Roma. Oggetto del provvedimento: procedura di mutuo riconoscimento n. FR/V/xxxx/IA/080/G. Si autorizza l'aggiornamento del RCP e degli stampati illustrativi per renderli conformi alla decisione della Commissione europea, C(2017) 6577 final, del 25 settembre 2017. Pertanto vengono modificati i seguenti punti del RCP: 4.5. Precauzioni speciali per l'impiego. Aggiungere il seguente paragrafo: «Altre precauzioni che riguardano l'impatto sull'ambiente»;
5 Proprieta' farmacologiche. Aggiungere il seguente paragrafo «5.3. Proprieta' ambientali»;
6.6. Precauzioni particolari da prendere per lo smaltimento del medicinale veterinario non utilizzato e dei...
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