Suvaxyn PRRS MLV - opinion on variation to marketing authorisation

Opinion

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

porcine respiratory and reproductive syndrome virus, live

Opinion

On 12 February 2026, 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 product Suvaxyn PRRS MLV. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium.

Suvaxyn PRRS MLV is currently authorised for administration via the intramuscular or intranasal route. This variation concerns the addition of an option to administer Suvaxyn PRRS MLV (0.5‑ml dose only) to pigs for fattening intramuscularly using a needle‑free device.

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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Note: Applicants 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 opinion for Suvaxyn PRRS MLV (EMA/VRA/0000269293)

Adopted Reference Number: EMADOC-1700519818-2885543

Key facts

• Name of medicine:
  Suvaxyn PRRS MLV
• EMA product number:
  EMEA/V/C/004276
• Active substance:
  modified live porcine respiratory and reproductive syndrome virus
• International non-proprietary name (INN) or common name:
  porcine respiratory and reproductive syndrome virus, live
• Date of opinion:
  12/02/2026
• Status:
  Positive