Committee for Medicinal Products for Veterinary Use: Withdrawal assessment report for Naxcel 200 mg/ml suspension for injection for horses.

On 5 May 2009, Pfizer Ltd 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 …