Review Product Marketing Authorisation For Veterinary Use "terramycin Long Acting Injectable Soluzioneacquosa '.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Terramicina Long Acting» soluzioneacquosa iniettabile.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-18&atto.codiceRedazionale=15A03571&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved April 15, 2015 # 242 measure of veterinary medicinal product: TERRAMYCIN LONG ACTING injectable aqueous solution.
Packaging: A.I.C. # 100088.
A.I.C. holder: Zoetis Italy S.r.l.-Via Andrea Doria # 41 M (00192 Roma-RM).
The object of the measure: Variation of type IAIN n. b. II b. 2 c. 2-importer level change of method of batch release and quality control tests on the finished product. Addition of a manufacturer responsible for the importation and/or batch release. Including batch control/testing.
You authorize the addition of the new production site Zoetis Manufacturing & Research Spain S.L.-Carretera Camprodon s/n, «La Riba», 17813 Vall de Bianya-Girona (Spain)-that takes care of the production, packaging, control and batch release of the finished product.
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.