CVMP Adopted Positive Opinion for New Vaccine for the Active Immunisation of Chickens

| By | EMA, Veterinary drugs
0
137

The Committee for Medicinal Products for Veterinary Use (CVMP) adopted by consensus a positive opinion for an initial marketing authorisation application for Vectormune FP ILT + AE, from Ceva-Phylaxia Co. Ltd, a new vaccine for the active immunisation of chickens to reduce skin lesions due to fowlpox, clinical signs and tracheal lesions resulting from avian infectious laryngotracheitis, and to prevent egg production losses due to avian encephalomyelitis.

The Committee adopted by consensus positive opinions for initial marketing authorisation applications for Tulissin (tulathromycin) from Virbac and for Tulaven (tulathromycin) from Ceva Santé Animale, both new generic products for the treatment and metaphylaxis of bovine respiratory disease, treatment of infectious bovine keratoconjunctivitis, treatment and metaphylaxis of swine respiratory disease and treatment of the early stages of infectious pododermatitis in sheep.

The Committee adopted by consensus a positive opinion for a type II variation application for Clynav to extend the duration of immunity from 3 to 12 months. The Committee adopted by consensus a positive opinion for a type II variation application (subject to a worksharing procedure) for Porcilis PCV M Hyo to modify the product information to include associated use combinations for Porcilis PCV M Hyo, Porcilis Lawsonia and Porcilis PRRS.

The Committee adopted by consensus positive opinions for type II variation applications for Evicto, for Imrestor and for Panacur AquaSol, all concerning quality-related changes.

The Committee also adopted by consensus positive opinions for type IB variation applications (subject to worksharing procedures) concerning quality-related changes for Bravecto, Bravecto Plus and Exzolt, and for Vaxxitek HVT+IBD and other related nationally authorised products.

SOURCE: EMA
SHARE
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.