Kexxtone

Application withdrawn

The application for this medicine has been withdrawn

Overview

On 17 April 2007 Eli Lilly and Company Ltd submitted to the EMEA an application for the granting of a Community marketing authorisation for Kexxtone.The active substance of Kexxtone is avilamycin, an oligosaccharide antibiotic which acts by inhibiting the protein synthesis of susceptible micro-organisms. The product is presented as a premix for medicated feeding stuff.The product was intended to be used in rabbits in cases of enteritis at the group level, prevention of mortality and digestive signs due to Clostridium perfringens susceptible to avilamycin. The proposed dosage is 7 mg avilamycin/kg bodyweight, which corresponds to approximately 80 mg avilamycin/kg feed for 4 weeks. The proposed withdrawal period was zero days.The CVMP on the basis of quality, safety and efficacy data submitted, considered that the product was not approvable at Day 120 since major objections had been identified regarding the quality of the active ingredient. Other points of concern related to the proposed incorporation rate in the feed, potential risks to the user, potential risk to the environment and providing adequate justification for the proposed dose regimen.On 8 September 2008 Eli Lilly and Company Ltd withdrew the application at day 120 of the procedure.

Withdrawal assessment report for Kexxtone

Adopted Reference Number: EMEA/12430/2009

Key facts

• Name of medicine:
  Kexxtone
• EMA product number:
  EMEA/V/C/000131
• Marketing authorisation applicant:
  Elanco animal health
• Withdrawal of application:
  08/09/2008

All documents

Withdrawal assessment report for Kexxtone

Adopted Reference Number: EMEA/12430/2009