Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-24&atto.codiceRedazionale=15A02138&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Extract from the measure # 118 of February 24, 2015 subject: veterinary medicinal product PRILENAL.
Mutual recognition procedure change number FR/V/0152/001-005/IA/0006 type IA variation, C.I. 3 Packs: A.I.C. # 103743 A.I.C. Holder: Ceva animal health S.p.A. with headquarters in Agrate Brianza (MB)-Viale Colleoni, 15-C.F. 09032600158.
You authorize changes to the summary of product characteristics and patient handouts.
The effect of this change is adding the phrase below indicated in section 4.5 special precautions for use of the SPC and 12 special warning (s) of the package insert: 4.5 special precautions for use special precautions to be taken by the person administering the veterinary medicinal product to animals.
"Pregnant women should pay particular attention to avoiding accidental contact because it was found that ACE inhibitors affect the fetus during pregnancy".
Lots already products may be marketed until their date of expiry.
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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