The Committee adopted by consensus a positive opinion for a marketing authorisation under exceptional circumstances for Hepizovac (Epizootic haemorrhagic disease vaccine (inactivated)), from CZ Vaccines S.A.U., a new vaccine intended for the active immunisation of cattle to prevent viraemia caused by serotype 8 of the epizootic haemorrhagic disease virus.
The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Nobilis Multriva IBm+ND+EDS, for the active immunisation of chickens for reduction of respiratory signs and egg drop caused by infectious bronchitis virus (IBV) strains Massachusetts (GI-1 genotype) and 4/91-793B (GI-13 genotype); for reduction of mortality and clinical signs caused by Newcastle disease virus (NDV); and for reduction of egg drop and eggshell defects caused by eggdrop syndrome-1976 virus (EDSV).
The Committee adopted by consensus a positive opinion for a marketing authorisation from Vetcare Oy for Prevestrus vet (finrozole), a product intended to shorten the pro-oestrus and oestrus period, reduce clinical signs of heat and reduce the risk of pregnancy in dogs (bitches).
The Committee adopted by consensus a positive opinion for a marketing authorisation from Vethellas S.A. for Prazivetin (praziquantel), for the treatment of ectoparasitic infestations of the gills of sea breams caused by monogenean trematodes principally of the species Sparicotyle chrysophrii.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Rheumocam (meloxicam), to add a new strength of 2 mg/ml solution for injection for cats.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Osurnia (terbinafine/florfenicol/betamethasone acetate), to implement the outcome of the MAH’s signal management process in the product information regarding ocular adverse events in dogs.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.x of the QRD template for:
The Committee adopted four scientific advice reports, of which two concerned biological products for dogs, one pharmaceutical product for cats and one pharmaceutical product for dairy cows/heifers. The Committee also endorsed a clarification of a scientific advice report for an immunological product for dogs.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following three requests, the CVMP classified:
The European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project previously collected information from 2009 to 2023 on how antimicrobial medicines are used in animals across the EU. The ESVAC project, with the voluntary participation of 31 reporting European countries, formally came to an end in November 2023 with the publication of its final report.
Now, under Regulation (EU) 2019/6, the collection of data on sales of veterinary antimicrobials and on the use of antimicrobials in animals became a mandatory activity for Member States, who are obliged to report this data to the EMA. The Agency, in turn, cooperates with Member States to publish an annual report on the data.
This month, the Committee adopted the first European Sales and Use of Antimicrobials for veterinary medicine report - Annual surveillance report for 2023, and in accordance with Article 17(1) of Commission Delegated Regulation (EU) 2021/578, it was agreed that publication on the EMA website will take place on 31 March 2025.
The Committee adopted the revised mandate, objectives, and rules of procedure for the Committee for Veterinary Medicinal Products (CVMP) Pharmacovigilance Working Party (PhVWP-V) (EMA/CVMP/PhVWP/133883/2004-Rev.8).
The CVMP meeting was followed by EMA Veterinary Innovation Day on 13-14 March 2025 targeted at veterinary pharmaceutical industry and smaller innovators. Three years after Regulation (EU) 2019/6 became applicable and 7 years after the first EMA Veterinary Innovation Day, EMA hosted a second edition to present and discuss an overview of the status of innovation in the EU. The event also provided a recap of the available regulatory support for innovation and opportunities for interaction.
More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.