Naxcel - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
ceftiofur
Post-authorisationVeterinary
On 5 May 2009, Pfizer Limited submitted an application for an extension of the Community marketing authorisation for Naxcel for a new target species, horses (200 mg/ml suspension for injection for horses), in accordance with Article 2(a) of Commission Regulation (EC) No 1085/2003 and Annex II.Naxcel 200 mg/ml suspension for injection for horses used the same formulation and presentation as for Naxcel 200 mg/ml suspension for injection for cattle and was presented in 100 ml glass vials. The proposed indication was for the treatment of respiratory tract infections in horses associated with Streptococcus equi subsp. zooepidemicus and other relevant susceptible bacterial pathogens. The proposed route of administration was intramuscular use.Since this application concerned 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, which was acceptable.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 mainly in relation to the efficacy at the suggested dose level but tolerance was also an issue to be taken into consideration in the benefitrisk assessment.On 4 February 2010, Pfizer Limited withdrew the application at Day 120 of the procedure.