Summary of opinion: Suvaxyn PRRS MLV, 19/06/2024 Positive
On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Suvaxyn PRRS MLV. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium.
Suvaxyn PRRS MLV is currently authorised as lyophilisate and solvent for suspension for injection. The variation is to change the product information related to the use in lactating sows and consequential adverse events in this subcategory of animals.
Based on the new data presented, the use of Suvaxyn PRRS MLV in lactating sows is acceptable; the identified adverse events for this subcategory of animals when using Suvaxyn PRRS MLV are described as of very common observation, which include elevated temperature, decreased appetite and injection site swelling.
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.
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
