Modificazione dell'autorizzazione all'immissione in commercio, della specialita' medicinale per uso veterinario .
Provvedimento n. 141 del 28 giugno 2006
Specialita' medicinale per uso veterinario: FRISKIES PROCONTROL GOCCE antiparassitario e disinfestante per uso esterno, nella confezione: astuccio con 6 tubetti da 1 ml - A.I.C. n. 103606012.
Titolare A.I.C.: Schering-Plough S.p.a. con sede legale in Milano - via G. Ripamonti n. 89 - codice fiscale 00889060158.
Oggetto: variazione tipo Ib: aggiornamento della parte II del dossier di registrazione - sostituzione di un eccipiente con un altro comparabile.
E' autorizzata la variazione tipo Ib della specialita' medicinale per uso veterinario indicata in oggetto, concernente l'aggiornamento della parte II del dossier di registrazione e, precisamente:
sostituzione dell'eccipiente autorizzato 2-(2metossietossi) etanolo con il propilen glicole monometil etere (dowanol PM);
estensione del periodo di validita' da 24 a 48 mesi;
modifica del sommario delle caratteristiche del prodotto, al punto 5.4 ´Effetti indesideratiª che ora e' il seguente:
´Con il principio attivo permetrina possono, anche se raramente...
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