Suiseng Diff/A - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

clostridioides difficile / clostridium perfringens vaccine, inactivated

Opinion

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.

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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 opinion for Suiseng Diff/A

Adopted Reference Number: EMA/CVMP/436655/2023

Key facts

• Name of medicine:
  Suiseng Diff/A
• EMA product number:
  EMEA/V/C/005596
• Active substance:
  • Clostridioides difficile toxoid A
  • Clostridioides difficile toxoid B
  • Clostridium perfringens, type A, alpha toxoid
• International non-proprietary name (INN) or common name:
  • clostridioides difficile
  • clostridium perfringens vaccine, inactivated
• Species:
  Pigs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI09AB12
• Marketing authorisation holder:
  Laboratorios Hipra, S.A.
• Date of opinion:
  05/10/2023
• Status:
  Positive