Draxxin - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
tulathromycin
Post-authorisationVeterinary
Overview
On 17 January 2007 Pfizer Ltd officially notified the Committee for Medicinal Products for Veterinary Use (CVMP) that it wishes to withdraw its application for a new indication for the treatment of bovine interdigital necrobacillosis associated with Bacteroides melaninogenicus, Bacteroides nodosus and Fusobacterium necrophorum.
Questions and answers on the withdrawal of the application to change the marketing authorisation application for Draxxin
International non-proprietary name (INN) or common name
tulathromycin
Date of withdrawal
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 90').