COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Spiramicina 20% liquido Chemifarma 820.000 UI/ml». (11A10318)
Provvedimento n. 136 del 5 luglio 2011
Specialita' medicinale per uso veterinario SPIRAMICINA 20% liquido chemifarma 820.000 UI/ml, soluzione per uso in acqua da bere per suini e broilers, nelle confezioni:
bottiglia da 100 g - A.I.C. n. 103405015;
bottiglia da 1 kg - A.I.C. n. 103405027;
tanica da 5 kg - A.I.C. n. 103405039.
Titolare A.I.C.: Chemifarma S.p.a. con sede legale e domicilio fiscale in Forli', via Don Eugenio Servadei, 16 - codice fiscale 00659370407.
Oggetto del provvedimento: variazione tipo II: aggiornamento dossier tecnica farmaceutica.
Si autorizza, per la specialita' medicinale per uso veterinario indicata in oggetto, la variazione tipo II concernente l'aggiornamento del dossier di tecnica farmaceutica, presentato dalla societa' titolare in data 23 marzo 2010 (Vs. rif. Nota del 18 marzo 2010) e successive integrazioni, ad eccezione dell'introduzione di due nuovi lotti delle dimensioni pari a 500 L e 1.000 L.
Le modifiche, apportate al dossier di tecnica farmaceutica che impattano sugli stampati sono le seguenti:
3) modifica dell'unita' di misura di espressione del contenuto delle confezioni attualmente autorizzate da: g(kg) a: ml(L);
4) modifica del confezionamento primario: da «bottiglia» a «flacone». Si tratta di una modifica redazionale in quanto, nulla cambia nella natura e composizione del confezionamento primario che rimane quello attualmente autorizzato.
Pertanto le confezioni ora autorizzate sono le seguenti:
...
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