Cirbloc

Opinion

EMA has issued an opinion on this medicine

porcine circovirus vaccine (inactivated)

Overview

On 10 September 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the veterinary medicinal product Cirbloc, an emulsion for injection intended for pigs. The applicant for this veterinary medicinal product is CEVA-Phylaxia Zrt. 

Cirbloc is a veterinary vaccine containing ORF2 capsid protein of porcine circovirus type 2d (ATCvet code QI09AA07) as the active substance, which auto-assembles into virus-like particles and stimulates active immunity against porcine circovirus type 2d in pigs.

The benefit of Cirbloc is its efficacy in active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, and virus shedding caused by porcine circovirus type 2 infection, which was investigated in a number of pre-clinical and clinical field studies conducted to an acceptable standard.

The most common side effects are injection site swelling, which disappears spontaneously within nine days, and elevated temperature and lethargy, which resolve spontaneously by the next day. 

The full indication is: “For the active immunisation of pigs from three weeks of age to reduce viraemia, virus load in the lungs and lymphoid tissues, and virus shedding caused by porcine circovirus type 2 (PCV2) infection.
Onset of immunity: 2 weeks after vaccination
Duration of immunity: 23 weeks after vaccination.”

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), which will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Cirbloc and therefore recommends the granting of the marketing authorisation.

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Notes: 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 summary of positive opinion for Cirbloc

Adopted Reference Number: EMA/CVMP/198585/2026

Product details

• Name of medicine:
  Cirbloc
• Active substance:
  porcine circovirus type 2d, ORF2 capsid protein
• International non-proprietary name (INN) or common name:
  porcine circovirus vaccine (inactivated)
• Species:
  Pigs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI09AA07
• EMA product number:
  EMEA/V/C/006873
• Marketing authorisation applicant:
  CEVA-Phylaxia Zrt.
• Opinion adopted:
  10/09/2026
• Opinion status:
  Positive