Review Product Marketing Authorisation For Veterinary Use "dexa-Ject 2 Mg/ml.».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Dexa-Ject 2 mg/ml.».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-14&atto.codiceRedazionale=15A01915&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Excerpt from the January 27, 2015 European procedure Number # 54 measure: IE/V/0293/II/004/G veterinary medicinal product DEXA-JECT 2 mg/ml solution for injection for cattle, pig, horse, dog and cat (A.I.C. Nos 104432).
Owner: DOPHARMA RESEARCH B.V. based in 24-4941 Zalmweg VX Raamsdonksveer-Netherlands.
You authorize:-the addition of the specification at the end of validity of the finished product on the impurities C, D, E and F of ≤ 0.5%-the extension of the period of validity of the medicinal product as packaged for sale from 18 months to 3 years the relative change to the extension of the period of validity of the medicine changes the point 6.3 of SPC, as follows : 6.3 validity period of storage of the veterinary medicinal product as packaged for sale: 3 years validity term 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.