Draxxin: Withdrawal of the application to change the marketing authorisation


Table of contents


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.

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
  • tulathromycin
Active substance
  • tulathromycin
Date of withdrawal
Company making the application
Zoetis Belgium SA
Withdrawal type

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 An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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