CVMP Adopted Positive Opinion For Marketing Application For Cimalgex

The Committee for Medicinal Products for Veterinary Use, or CVMP, said Friday it adopted by consensus a positive opinion for a marketing authorization application for Cimalgex, cimicoxib, from Vetoquinol SA (VETOF), for the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-operative pain due to orthopedic or soft tissue surgery, in dogs.

MAIN FACTS:

-Committee adopted by consensus a positive opinion for a marketing authorization application for Comfortis, spinosad, from Eli Lilly and Company Ltd (LLY), for the treatment and prevention of flea infestations in dogs.

-Committee adopted by consensus a positive opinion for a marketing authorization application for ACTIVYL, indoxacarb, from Intervet International BV, for the treatment and prevention of flea infestations in cats and dogs.

-Committee adopted by consensus a positive opinion for a marketing authorization application for Purevax Rabies from MERIAL, for the active immunization of cats to prevent mortality due to rabies infection.

-Committee adopted by consensus a positive opinion for a marketing authorization application for Melosus, meloxicam, from CP-Pharma Handelsgesellschaft mbH, for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs and the alleviation of inflammation and pain in chronic musculo-skeletal disorders in cats.

-Committee adopted by consensus a positive opinion for a type II variation application for Zulvac 8 Ovis and ZOLVIX.

-Committee also adopted by consensus a negative opinion for a type II variation application for Masivet.

-Committee agreed scientific advice concerning the establishment of an MRL for horses as a follow-up request to advice previously given.

-Committee also agreed scientific advice for review of dossier requirements in line with the MUMS guidelines for an immunological product for sheep and goats.

-By Tapan Panchal, Dow Jones Newswires. Tel [phone], [e-mail]