Modification Of A Marketing Authorisation For Veterinary Product «Deltanil» 10 Mg/ml Solution Pour-For Regular Switching Times Cattle And Sheep.
Original Language Title: Modificazione 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=15A00164&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Extract from the measure # 1018 of December 19, 2014 veterinary medicinal product: DELTANIL 10 mg/ml solution pour-on for cattle and sheep (A.I.C. nn. 104478045-058).
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/006.
You authorize the extension of the period of validity after first opening the immediate packaging of the medicinal product packaging indicated, Sun from 12 months to 24 months.
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: 24 months.
Period of validity: 12 months after first opening the vial.
Period of validity after first opening flexible bag: 24 months.
It also amended section 4.9 of the SPC on amending of pictograms, inserting the image the use of gloves in the first step and the image of the use of the apron in the last step.
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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