Zubrin - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
tepoxalin
Post-authorisationVeterinary
On 4 September 2007, S-P Veterinary submitted to the EMEA an application for the extension of a marketing authorisation for Zubrin for a new pharmaceutical form (Zubrin 100 mg/ml oral suspension for dogs).The proposed form was presented in glass bottles and was indicated for use in dogs for the reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. The route of administration was oral use. At present the product is authorised for dogs in three strengths (50, 100 and 200 mg) as oral lyophilisates in the same indications.Since this application concerns the extension to an already authorised veterinary medicinal product, cross-reference was made to relevant sections of dossier(s) already submitted and assessed by the CVMP an previous occasions.The CVMP on the basis of quality, safety and efficacy data submitted, considered that the application was not approvable at Day 120 since major objections had been identified, which precluded a recommendation for marketing authorisation. The concerns were in relation to the efficacy and safety of Zubrin oral suspension at the suggested dose level.On 3 October 2008, S-P Veterinary withdrew the application at Day 120 of the procedure.