Overview

On 18 July 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Porcilis PCV M Hyo ID, emulsion for injection, intended for pigs. The applicant for this veterinary medicinal product is Intervet International B.V.

Porcilis PCV M Hyo ID is an immunological veterinary medicinal product containing porcine circovirus type 2, ORF2 capsid protein and Mycoplasma hyopneumoniae, strain J, inactivated (ATCvet code QI09AL08) as active substances. The product stimulates the development of active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs.

The benefit of Porcilis PCV M Hyo ID is the active immunisation of pigs to reduce viremia, virus load in lungs and lymphoid tissues, and faecal virus shedding caused by porcine circovirus type 2 (PCV2) infection and severity of lung lesions caused by Mycoplasma hyopneumoniae infection and to reduce the loss of daily weight gain during the finishing period in face of infections with PCV2 and/or M. hyopneumoniae.

The most common side effects are elevated temperature, injection site swelling and injection site scabs.

The full indication is:

For the active immunisation of pigs to reduce viremia, virus load in lungs and lymphoid tissues, and faecal virus shedding caused by porcine circovirus type 2 (PCV2) infection and severity of lung lesions caused by Mycoplasma hyopneumoniae infection and to reduce the loss of daily weight gain during the finishing period in face of infections with PCV2 and/or M. hyopneumoniae.

Onset of immunity:

PCV2: 2 weeks after vaccination,

M. hyopneumoniae: 4 weeks after vaccination.

Duration of immunity:

PCV2: 26 weeks after vaccination,

M. hyopneumoniae: 18 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 Porcilis PCV M Hyo ID and therefore recommends the granting of the marketing authorisation.

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 summary of positive opinion for Porcilis PCV M Hyo ID

AdoptedReference Number: EMA/CVMP/303620/2024

English (EN) (135.28 KB - PDF)

First published:
View

Product details

Name of medicine
Porcilis PCV M Hyo ID
Active substance
  • porcine circovirus type 2, ORF2 capsid protein
  • Mycoplasma hyopneumoniae, strain J, inactivated
International non-proprietary name (INN) or common name
Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) code
  • QI09AL08
  • QI09
EMA product number
EMEA/V/C/006289
Marketing authorisation applicant
Intervet International B.V.
Opinion adopted
18/07/2024
Opinion status
Positive
This page was last updated on

Share this page