Review Of The Marketing Authorisation For Veterinary Product «Torphasol» Soluzioneiniettabile 4 Mg/ml For Cats And Dogs.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Torphasol» 4 mg/ml soluzioneiniettabile per cani e gatti.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-10&atto.codiceRedazionale=15A00805&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Excerpt from the January 19, 2015 TORPHASOL # measure 36 medicinal 4 mg/ml solution for injection for dogs and cats (A.I.C. nn. 104425018-020).
Owner: A.I.C. aniMedica GmbH, Im Südfeld 9-48308 Senden-Bösensell-Germany.
The object of the measure: European Procedure Number: IE/V/0232/001/IB/010 authorizing the extension of the period of validity of the medicinal product as packaged for sale from 2 years to 3 years.
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: 3 years.
Period of validity after first opening the immediate packaging: 28 days.
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.