Zactran

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Questions & Answers

On 16 March 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of an extension to the marketing authorisation for the veterinary medicinal product Zactran. The applicant for this veterinary medicinal product is MERIAL.

Zactran is currently authorised for use in cattle and pigs. The extension concerns the addition of a new food-producing target animal species, sheep, for the following indication: "For the treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment."

The most common adverse reactions in sheep are transient injection site swellings.

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 Zactran and therefore recommends the granting of the extension to the marketing authorisation.


1Applicants 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 post-authorisation summary of positive opinion for Zactran (X/0034) (English only) 2017-03-17  

Key facts

Product details for Zactran
NameZactran
INN or common name

gamithromycin

Active substance

gamithromycin

Date opinion adopted16/03/2017
Company name

MERIAL

StatusPositive
Application typePost authorisation