The European Medicines Agency highlights the latest news on veterinary medicines.
The Committee for Medicinal Products for Veterinary Use of the European Medicines Agency has held its last meeting from February 14 to 16
This Friday, February 17, the European Medicines Agency (EMA) has published the highlights of the second meeting of its Committee on Veterinary Medicines in 2023 (CVMP), which took place between the 14th and 16th of this month.
Within the framework of this meeting, the Committee adopted a draft guideline on plasmid DNA vaccines for veterinary use for a public consultation period of 4 months. This guideline has been developed to provide advice to manufacturers applying for marketing authorization of nucleic acid vaccines for use in animals when the vaccine consists of bacterial or synthetic plasmid DNA. It applies to DNA vaccines, which consist of plasmid DNA that is not amplifiable in eukaryotic cells.
Also during this meeting and in accordance with the Regulation (EC) No. 726/2004the Committee adopted by consensus several positive opinions for marketing authorization applications for veterinary medicines.
Thus, the CVMP adopted by consensus a positive opinion for a marketing authorization application for Bovilis Nasalgen-C, of Msd Animal Health, a new vaccine for the active immunization of cattle from the day of birth to reduce clinical signs of upper respiratory tract and nasal disease. viral excretion of bovine coronavirus infection.
Likewise, the Committee adopted by consensus a positive opinion for a application for extension of marketing authorization existing for Coxevac (vaccine Coxiella burnetii (inactivada)), of Something Salud Animalconcerning the addition of a new target species: sheep.
The Committee adopted by consensus a positive opinion for a marketing authorization application for Innovax-ILT-IBD (Marek’s disease, avian infectious laryngotracheitis and infectious bursal disease vaccine (live recombinant)), from Msd Animal Healtha new vaccine for the active immunization of day-old chicks or 18-19 day-old embryonated hens’ eggs to reduce mortality, clinical signs, and lesions caused by avian infectious laryngotracheitis (ILT) virus and Avian Infectious Laryngotracheitis (ILT) virus. Marek’s disease (MD) and to prevent mortality and reduce clinical signs and lesions caused by the infectious bursal disease (IBD) virus.
The Committee adopted, by consensus, a positive opinion for a marketing authorization application for Eurycan L4 (vaccine against canine leptospirosis), of Boehringer Ingelheim Vetmedica GmbHa new vaccine for the active immunization of dogs from 7 weeks of age to prevent or reduce mortality, clinical signs, infection, bacterial excretion, renal carriage and renal lesions due to canine leptospirosis.
Finally, the Committee adopted, by consensus, a positive opinion for a marketing authorization application for Trya request for informed consent, of Zoetisa new product for the treatment of pruritus associated with allergic dermatitis in dogs and the treatment of clinical manifestations of atopic dermatitis in dogs.
