COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Ventipulmin 25 mcg/ml» sciroppo per cavalli non destinati alla produzione di alimenti per il consumo umano (NDPA). (14A09379)
Estratto del provvedimento n. 930 del 14 novembre 2014 Medicinale veterinario VENTIPULMIN 25 mcg/ml sciroppo per cavalli non destinati alla produzione di alimenti per il consumo umano (NDPA). Confezioni: flacone da 355 ml - n. A.I.C. 100033036. Titolare A.I.C.: Boehringer Ingelheim Vetmedica GmbH con sede in Binger Strasse 173 - Ingelheim AM Rhein - 55216 Germania. Modifica: variazione tipo IB unforeseen (C.I.z.): modifica del riassunto delle caratteristiche del prodotto e degli stampati illustrativi per adeguamento al QRD template;
variazione tipo IB unforeseen (C.I.z.): modifica del regime di dispensazione da ricetta medico veterinaria in triplice copia non ripetibile a ricetta medico veterinaria in copia unica non ripetibile. Si autorizzano le modifiche come di seguito descritto. 2. Composizione qualitativa e quantitativa Un ml contiene: clembuterolo cloridrato 0,025 mg pari a 0,022 mg di clembuterolo. 4.6 Reazioni avverse E' aggiunta la frase: la frequenza delle reazioni avverse e' definita usando le seguenti convenzioni: molto comuni (piu' di 1 animale su 10 mostra reazioni avverse durante il corso di un...
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