CVMP opinions on veterinary medicinal products

The Committee adopted, by consensus, a positive opinion for a marketing authorisation application for Prolevare, an informed consent application, from Zoetis Belgium, a new product for the treatment of pruritus associated with allergic dermatitis in dogs and treatment of clinical manifestations of atopic dermatitis in dogs¹.

Under Regulation (EU) 2019/6

The Committee adopted by consensus positive opinions for variation requiring assessment to align the product information with version 9.0 of the QRD template for:

• Bravecto Plus – grouped procedure including addition of a new therapeutic indication for the prevention of aelurostrongylosis (by preventing the establishment of adult Aelurostrongylus abstrusus responsible for clinical disease)
• Zeleris – grouped procedure including addition of a new therapeutic indication for the treatment of bovine respiratory disease due to Mycoplasma bovis associated with pyrexia
• Aservo EquiHaler –…