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Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.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

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

Reference Number: EMEA/CVMP/58270/2007

Key facts

• Name of medicine:
  Draxxin
• EMA product number:
  EMEA/V/C/000077
• Active substance:
  tulathromycin
• International non-proprietary name (INN) or common name:
  tulathromycin
• Species:
  • Pigs
  • Cattle
  • Sheep
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QJ01FA94
• Marketing authorisation holder:
  Zoetis Belgium SA
• Date of issue of marketing authorisation valid throughout the European Union:
  11/11/2003
• Date of withdrawal:
  17/01/2007