Zoetis statement on CVMP opinion relative to Suvaxyn PRRS MLV
No product-specific concern identified for Suvaxyn PRRS MLV and benefit/risk balance for the product remains favourable.Zoetis welcomes the CVMP opinion, announced on May 25th, relative to the Suvaxyn PRRS MLV (live attenuated vaccine) referral procedure under Article 45 of Regulation (EC) N° 726/2004.
“Zoetis is very pleased that the CVMP concluded that there is no product-specific concern identified for Suvaxyn PRRS MLV and that the benefit/risk balance for the product remains favourable,” said Thomas Hilligsøe, General Manager for the Nordics.
Zoetis supports the addition of a precautionary warning to the Suvaxyn PRRS MLV labelling in order to mitigate the risk of vaccine strain recombination with other PRRS MLV vaccine strains.
“We are looking forward to working with the Danish Authorities on the next steps in Denmark,” concluded Hilligsøe.