Suvaxyn PRRS MLV

Porcine respiratory and reproductive syndrome virus vaccine (live)

Opinion

On 16 April 2019, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, 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 (MAH) for this veterinary medicinal product is Zoetis Belgium SA.

Suvaxyn PRRS MLV is currently authorised as lyophilisate and solvent for suspension for injection. The variation concerns the reduction of the onset of immunity for fattening pigs and gilts and sows from 28 days to 21 days and the extension of the duration of immunity for gilts and sows from 16 weeks to 26 weeks.

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 revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.


1 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.

 

Key facts

Name
Suvaxyn PRRS MLV
Agency product number
EMEA/V/C/004276
International non-proprietary name (INN) or common name
  • Porcine respiratory and reproductive syndrome virus vaccine (live)
Species
Pigs
Active substance
  • Modified live porcine respiratory and reproductive syndrome virus
Date opinion adopted
16/04/2019
Company name
Zoetis Belgium SA
Status
Positive
Application type
Post-authorisation

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