Exzolt

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Questions & Answers

On 15 June 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 Exzolt, 10 mg/ml solution for use in drinking water, intended for the treatment of poultry red mite (Dermanyssus gallinae) infestation in chickens. The applicant for this veterinary medicinal product is Intervet International B.V.

Exzolt is an antiparasitic medicinal product containing fluralaner (ATCvet code QP53BE02) as the active substance. Fluralaner is an isoxazoline ectoparasiticide which is systemically active against the mites.

The benefits of Exzolt are its efficacy in the treatment of poultry red mite (Dermanyssus gallinae) infestation in chickens (pullets, breeders and layer hens).

Exzolt is well tolerated at the recommended dose.

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 Exzolt 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 Exzolt (English only) 2017-06-16  

Key facts

Product details for Exzolt
NameExzolt
INN or common name

fluralaner

Active substance

fluralaner

Date opinion adopted15/06/2017
Company name

Intervet International B.V.

StatusPositive
Application typeInitial authorisation