Review Product Marketing Authorisation For Veterinary Use «Leventa», 1 Mg/ml Oral Solution Percani.
Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Leventa», 1 mg/ml soluzione orale percani.
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-18&atto.codiceRedazionale=15A03580&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved April 8, 2015 # measure 227 of the veterinary medicinal product LEVENTA, 1 mg/ml oral solution for dogs 30 ml 1 bottle packaging: A.I.C. # 103,826,018 6 bottles of 30 ml 30 ml # 103,826,020 12 bottles of A.I.C. A.I.C. # 103,826,032 type IB Variation, n. b. II. f. 1 European procedure # IE/V/0182/001/IB/009: Intervet International B.V. Boxmeer (Holland), represented in Italy by the company MSD Animal Health S.r.l. with registered office and tax domicile in Segrate (MI)-via Fratelli Cervi snc-Centro Direzionale Milano Due, Palazzo Canova-VAT # 01148870155.
You authorize the reduction of the period of validity of the veterinary medicinal product as packaged for sale from 3 years to 2 years.
The change above changes the point 6.3 of the SPC as follows: 6.3. Period of validity period of validity of the veterinary medicinal product as packaged for sale: 24 months.
Period of validity after first opening the immediate packaging: 6 months.
Veterinary medicinal product packages produced by at least 24 months must be withdrawn immediately, while those produced for less than 24 months must be appropriate with regard to the review of the validity, within 60 days from the date of publication of this decision.
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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