Oxybee

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Questions & Answers

On 7 September 2017,the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Oxybee, a powder and solution for bee-hive dispersion intended for the treatment of varroosis in honey bees. The applicant for this veterinary medicinal product is Dany Bienenwohl. The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

Oxybee is an antiparasitic medicinal product containing oxalic acid dihydrate (ATCvet code QP53AG03) as the active substance. The mode of action of oxalic acid dihydrate against the Varroa mite is still not well-known, although direct contact with mites is needed. The withdrawal period for honey is zero days.

The benefit of Oxybee is its effective use in treatment of honey bees in hives infested with Varroa destructor mites. Oxybee is generally well-tolerated at the recommended dose; however adverse reactions (dose-dependent increase in bee mortality) was commonly noted.

The appropriate CVMP guidelines on data requirements for veterinary medicinal products intended for minor use or minor species/limited markets have been applied in the assessment of the application.

Detailed conditions for the use of this product will be described in the summary of product characteristics (SPC), which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Oxybee and therefore recommends the granting of the marketing authorisation.


1 Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

Name Language First published Last updated
CVMP summary of positive opinion for Oxybee (English only) 2017-09-08  

Key facts

Product details for Oxybee
NameOxybee
INN or common nameoxalic acid dehydrate
Active substance

oxalic acid dehydrate

Date opinion adopted07/09/2017
Company name

Dany Bienenwohl

StatusPositive
Application typeInitial authorisation