CVMP opinions on veterinary medicinal products

Under Regulation (EU) 2019/6

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Gumbohatch (live Avian infectious bursal disease vaccine) concerning the amendment of the indication by adding its use in future layer chickens.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Vaxxitek HVT+IBD, Prevexxion RN+HVT+IBD, Prevexxion RN (subject to a worksharing procedure) concerning the update of the approved marketing authorisation dossier of each vaccine with a new clinical efficacy study studying the interaction between RN1250 and vHVT013-69 vaccine strains on infectious bursal disease protection.

The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:

• Melovem – to add a new strength and pharmaceutical form – a 15 mg/ml oral suspension for horses
• Purevax RCPCh , Purevax RCP FeLV,…