Review Of The Marketing Authorisation For Veterinary Product «Euthasol» Soluzioneiniettabile 400 Mg/ml For Dogs, Cats, Rodents, Rabbits, Cattle, Sheep, Goats, Horses And Mink (Yes).
Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Euthasol» 400 mg/ml soluzioneiniettabile per cani, gatti, roditori, conigli, bovini, pecore,capre, cavalli e visoni (gia' autorizzato).
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-16&atto.codiceRedazionale=15A01000&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Decree # 8 of January 21, 2015 checks out the marketing authorisation for the veterinary medicinal product "EUTHASOL" 400 mg/ml solution for injection for dogs, cats, rodents, rabbits, cattle, sheep, goats, horses and Minks, under the conditions mentioned below: A.I.C. Holder: The Vet B.V. based in Netherlands, Wilgenweg 7-3421 Oudewater-TV represented in Italy by the company Esteve S.p.A. with registered office in Via Ippolito Rossellini , 12-1 St floor 20124 Milan;
Manufacturer responsible for batch release: the plant Produlab Pharma B.V. based in Forellenweg 16, 4941 SJ Raamsdonksveer-Netherlands;
Authorised pack sizes and numbers of A.I.C.: 100 ml-bottle-250 ml bottle # 104322019-A.I.C.-A.I.C. # 104322021 composition: 1 ml of solution contains: active ingredient: Pentobarbital (equivalent to 400 mg of sodium pentobarbital) 362.9 mg excipients: as indicated in pharmaceutical techniques acquired to acts.
Target species: dogs, cats, rodents, rabbits, cattle, sheep, goats, horses and mink;
Medical indications: euthanasia;
Validity: validity of the veterinary medicinal product as packaged for sale: 3 years;
Period of validity after first opening the immediate packaging: 28 days;
Waiting time: You need to take the necessary measures to ensure that the carcasses of animals treated with this product and the byproducts of these animals do not enter the food chain and are not used for human or animal consumption;
Dispensing scheme: veterinary medicinal product included in the table of medicinal products-section A of P.r.decree 309/90 and amendments with ban on sale to the public. Administration and detention shall be carried out by a vet.
Date of Decree: immediate effect.
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