The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) concerning the addition of a new pharmaceutical form, 150 mg/ml powder and solvent for suspension for injection, for dogs.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Solensia (frunevetmab) to implement the outcome of the MAH’s signal management process, to include “skin disorders” as a rare adverse event. In addition, the MAH included some editorial changes in the Summary or Product Characteristics (SPC) section 10 – Classification of Veterinary Medicinal Products and package leaflet sections 7 – Adverse events and 15  Date on which the package leaflet was last revised, linked to the QRD template version 9.0.

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Frontpro (afoxolaner) to add a new therapeutic indication for the treatment of tick infestations…