DANY Bienenwohl GmbH to obtain positive opinion by CVMP for Oxybee

under Klifovet's guidance

In the first CVMP meeting after the summer break last week, CVMP gave a positive opinion to the centralised procedure marketing authorisation for Oxybee, an application made by DANY Bienenwohl GmbH and guided by KLIFOVET AG to reach this significant step for a bee veterinary medicinal product.

Nick Dany, general manager of Dany Bienenwohl GmbH comments: “we have reached a very relevant milestone allowing us to market the product soon, and make it available to most bee-keepers in the European Union. The investment was significant, but we have achieved now a fully GMP compliant product satisfying all current EU requirements.”.
Dr. Klaus Hellmann, CEO of KLIFOVET AG commented: “we are very proud to have been involved in this successful story to obtain a centralised marketing authorisation for the minor species bees and the most relevant disease of bees. The review process of CVMP was extremely short by keeping clock stop to a minimum. A well justified dossier is the best assurance for a short and successful application. Congratulations to all the team involved!”.
Oxybee will be introduced and distributed to most markets in the European Union shortly by Véto-pharma, a French pharmaceutical company fully dedicated to honey bee health.
The final EU marketing authorisation is expected to be received later this year and a launch is planned as soon as possible.