Review Product Marketing Authorisation For Veterinary Use «Lincospectin 222/444.7 Mg/g Preparations For Use In Drinking Water For Pigs And Chickens. "
Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Lincospectin 222/444,7 mg/g polvereper uso in acqua da bere per suini e polli».
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-09&atto.codiceRedazionale=15A01692&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Extract from the measure # 96 of February 16, 2015 European procedure number: BE/V/0029/IA/001/003.
Subject: veterinary medicinal product LINCOSPECTIN 222/444.7 mg/g powder for use in drinking water for pigs and chickens.
Packaging: all packaging (A.I.C. nn. 100237015-027).
A.I.C. holder: Zoetis Italy S.r.l. with registered office and tax domicile in Rome-via Andrea Doria, 41 M-fiscal code 12,000,641,006.
Review: Elimination of the site responsible for batch release.
You authorize, for the only packs shown in object, deleting the site Pfizer Service Company bvba, Hoge Wei 10, 1930 Zaventem (Belgium) from the responsibility of the batch release.
The effect of that review the package insert and labels shall be amended as follows: leaflet-labels: 1. name and address of the marketing authorisation holder and of the manufacturing authorisation holder of the batch release, if different.
Authorisation holder: Zoetis Italy S.r.l.-via Andrea Doria, 41 M-00192 Rome.
Manufacturer responsible for batch release of manufacture: Zoetis Belgium SA-Rue Laid Burniat 1, 1348 Louvain-la-Neuve (Belgium).
Lots already products can be marketed until the expiration date printed on the package.
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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