Authorisation For The Medicinal Product For 18.7 Mg/g Usoveterinario «Alverin».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Alverin 18,7 mg/g».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01489&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Decree No. 14 of February 10, 2015 veterinary medicinal product ALVERIN 18.7 mg/g oral paste for horses.
A.I.C. holder: Zoetis Italy S.r.l., with registered office and tax domicile in Rome, via Andrea Doria # 41-tax code # 12000641006.
Manufacturer responsible for batch release: society Cross Vetpharm Group Ltd. at the plant site in Broomhill Road, Tallaght, Dublin 24-Ireland.
Decentralized procedure # UK/V/0512/001/DC.
Authorised pack sizes and numbers of A.I.C.: box containing 1 syringe-A.I.C. # 104683014;
box containing 20 syringes-A.I.C. # 104683026.
Composition: active ingredient: ivermectin 18.7 mg/g;
other ingredients: pharmaceutical technology gained so as indicated in the record.
Target species: horses.
Medical indications: the veterinary medicinal product is indicated for the treatment of parasitic infections in horses due to: large redworms: Strongylus vulgaris (adult and Larval arterial), s. edentatus (adult and Larval tissues), s. equinus (adults), Triodontophorus spp. (adults)-Triodontophorus Craterostomun acuticaudatum Triodontophorus brevicauda, serratus-(adults);
small redworms: adult and immature stages (stage four larvae) of small redworms or small redworm benzimidazole-resistant strains, including: Coronocyclus spp. (Coronocyclus Coronocyclus labratus, Coronocyclus coronatus, labiatus), Cyathostomum spp. (Cyathostomum catinatum, Cyathostomum pateratum), Cylicocyclus spp. (Cylicocyclus ashworthi, leptostomum elongatus Cylicocyclus Cylicocyclus nassatus, Cylicocyclus insigne, Cylicocyclus Cylicocyclus radiatus,,), Cylicostephanus spp: (Cylicostephanus asymetricus, Cylicostephanus Cilicostephanus calicatus, Cylicostephanus Cylicostephanus bidentatus, goldi, longibursatus, Cylicostephanus minutus), Cilicodontophorus spp. (Cylicodontophorus bicornatus), Gyalocephalus capitatus, Parapoteriostomum spp. (Parapoteriostomum mettami, Parapoteriostomum euproctus), petrovinema spp. (Petrovinema poculatum), Poteriostomum spp. (Poteriostomum imparidentatum).
Pulmonary nematodes (adult and immature stages): Dictyocaulus arnfieldi.
Pinworms (adult and immature stages): Oxyuris granulomas.
Roundworms (adults and larvae on the third and fourth stage): Parascaris equorum.
Hairworm (adults): Trichostrongylus axei.
Habronema (adults): Habronema muscae.
Onchocerca (microfilariae): Onchocerca spp.
Intestinal nematodes (adults): Strongyloides westers.
Given (oral and gastric stages): oral and gastric stages of Muscina spp.
Validity: validity of the veterinary medicinal product as packaged for sale: 2 years.
This product is for single use only. Replace the CAP tightly after use and do not store any unused product.
Waiting time: meat and offal: 21 days.
Not permitted for use in mares producing milk for human consumption.
Dispensing scheme: to be supplied only upon presentation of medical veterinary prescription in triplicate not repeatable.
Date of Decree: immediate effect.