Naxcel: Withdrawal of the application to change the marketing authorisation



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.

Key facts

Product number
Date of issue of market authorisation valid throughout the European Union (if applicable)
International non-proprietary name (INN) or common name
  • ceftiofur
Active substance
  • ceftiofur
Date of withdrawal
Company making the application
Zoetis Belgium SA
Withdrawal type

Related content

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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