On 5 October 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion , recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal products CircoMax and CircoMax Myco. The marketing authorisation holder for these veterinary medicinal products is Zoetis Belgium.
The variation is to add the option of administering CircoMax and CircoMax Myco intramuscularly, using needle-free devices. Some editorial changes to the product information are proposed. The name of the marketing authorisation holder is corrected from Zoetis Belgium SA to Zoetis Belgium.
Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
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.
CVMP post-authorisation summary of positive for CircoMax
English (EN) (137.73 KB - PDF)