Summary of opinion: Suiseng Diff/A,clostridioides difficile,clostridium perfringens vaccine, inactivated, 05/10/2023, Positive
On 5 October 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Suiseng Diff/A. The marketing authorisation holder for this veterinary medicinal product is Laboratorios Hipra, S.A.
Suiseng Diff/A is currently authorised as suspension for injection. The variation concerns the addition of the associated use of the vaccine Suiseng Diff/A with the vaccine Suiseng Coli/C.
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
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