Review Of The Marketing Authorisation For Veterinary Product «Deltanil» 10 Mg/ml Solution Pour-For Regular Switching Times Cattle And Sheep.
Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Deltanil 10 mg/ml» soluzione Pour-onper bovini e ovini.
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-15&atto.codiceRedazionale=15A00165&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Extract from the measure # 1019 of December 19, 2014 veterinary medicinal product: DELTANIL 10 mg/ml solution pour-on for cattle and sheep (A.I.C. nn. 104478).
A.I.C. holder: VIRBAC 1ere avenue-2065m-L.I.D. -06516 Carros France.
The object of the measure: European procedure number: UK/V/0425/002/IB/005/G.
You authorize: the extension of the period of validity of the veterinary medicinal product as packaged for sale from 2 years to 3 years;
adding the site Cebiphar, 37230 Fondettes-1 Route de la Bodiniere-France as a site responsible for the control of the finished product.
The variation identified by the number of steps indicated above changes the point 6.3 of the SPC and its labels and package insert sections, as follows. 6.3 validity period of validity of the veterinary medicinal product as packaged for sale: 3 years.
Period of validity: 12 months after first opening the bottle.
Period of validity after first opening flexible bag: 24 months.
Lots already products may be marketed until their expiry date.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.
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