Authorisation For The Medicinal Product For Usoveterinario «Modulis» 100 Mg/ml Oral Solution For Dogs.

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Modulis» 100 mg/ml soluzione orale per cani.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-23&atto.codiceRedazionale=15A02132&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Decree No 22 of February 19, 2015 decentralised procedure # UK/V/0521/001/DC.
Veterinary medicinal product MODULIS 100 mg/ml oral solution for dogs.
A.I.C. holder: company Sogeval established in 200 Avenue De Mayenne-Zone Industrielle Des Touches-53000 Laval (France).
Manufacturer responsible for batch release: A.I.C. holder's company at the plant site in 200 Avenue De Mayenne-Zone Industrielle Des Touches-53000 Laval (France);
the company Laboratoires Biove at the plant site at 3 Rue de Lorraine-62510 Arques (France).
Authorised pack sizes and numbers of A.I.C.: cardboard box containing a 5 ml vial with 1 ml syringe-A.I.C. # 104707017 cardboard box containing a bottle of 15 ml with 1 ml syringe-A.I.C. # 104707029 carton box containing a bottle of 30 ml with 2 ml syringe-A.I.C. # 104707031 cardboard box containing one 50 ml bottle with 2 ml syringe-A.I.C. # 104707043 Composition : each ml contains: active ingredient: Cyclosporine 100 mg other ingredients: pharmaceutical technology gained so as indicated in the record.
Target species: dogs.
Medical indications: treatment of chronic manifestations of atopic dermatitis in dogs.
Validity: validity of the veterinary medicinal product as packaged for sale: 30 months;
period of validity after first opening the immediate packaging: 3 months.
Waiting time: not applicable.
Dispensing scheme: to be supplied only upon presentation of medical veterinary prescription in single copy not repeatable.
Date of Decree: immediate effect.