CVMP opinions on veterinary medicinal products

Under Regulation (EC) No 726/2004, the Committee adopted by consensus a positive opinion for a marketing authorisation application for Oxmax (hemoglobin betafumaril (bovine)), from New Alpha Innovation Biopharmaceutical Ireland Limited, a new product as an adjunct therapy in the management of haemorrhagic shock in dogs. 

Under Regulation (EU) 2019/6, the Committee adopted by consensus a positive opinion for a marketing authorisation application for Loxitab (meloxicam), from CP-Pharma Handelsgesellschaft mbH, a new generic product for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 

The Committee adopted by consensus a positive opinion for a marketing authorisation for Poulvac Procerta HVT-IBD, from Zoetis Belgium, a new vaccine for the active immunisation of one-day-old chickens and 18-19 day-old embryonated chicken eggs to reduce mortality, clinical signs and lesions caused by Marek’s disease virus, and prevent mortality and clinical signs and reduce lesions caused by infectious bursal disease virus.

The Committee adopted by consensus a positive opinion for a marketing authorisation for Prevexxion RN+HVT, from Boehringer Ingelheim Vetmedica GmbH, a new vaccine for the active immunisation of one-day-old chicks to prevent mortality and reduce clinical signs and lesions caused by Marek’s Disease (MD) virus (including very virulent MD virus).

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 focused on the frequency of anaphylaxis in cats. 

The Committee adopted by consensus a positive opinion for a grouping variations requiring assessment for Nexgard Spectra to lower the minimum bodyweight of target animals and to align the product information with version 9.0 of the QRD template.

The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:

  • Evanovo, Gumbohatch (worksharing procedure)
  • Felpreva
  • Nexgard Spectra
  • Nobivac DP Plus
  • Porcilis PCV M Hyo (grouped)
  • ProZinc
  • Simparica, MiPet Easecto (grouped, worksharing procedure)
  • Stelfonta (grouped)
  • Zenalpha

The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:

  • Clynav
  • Felisecto Plus
  • Innovax-ND-ILT
  • Leucofeligen FeLV/RCP
  • Previcox
  • Stronghold Plus

Union referrals and related procedures

The Committee concluded the referral procedure for veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection. The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns that the dosage regimen (dose rate and duration of treatment) for the concerned products might not be appropriate to ensure effective use of these medicines, which could also contribute to the development of antimicrobial resistance. The Committee adopted by majority an opinion recommending changes to the indications, dosage regimen, warnings on the effective use of the products, as well as to the withdrawal periods. The Committee concluded that the benefit-risk balance of veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection remains favourable and that those marketing authorisations should be amended.

Scientific advice

The Committee adopted four scientific advice reports further to requests for initial and follow-up advice concerning one immunological and three pharmaceutical products. The respective target species were turkeys (one product), cattle (one product), and horses (two products).

Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6

Following two requests, the CVMP classified:

  • A product (ATCvet classification: Antiparasitic products, insecticides and repellents) for ornamental birds, pet rabbits, rats, mice and reptiles as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6. 
  • A product (ATCvet classification: Alimentary tract and metabolism) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6. 

Concept papers, guidelines and SOPs

Safety

The Committee adopted a draft concept paper on the revision of the guideline on user safety of topically administered veterinary medicinal products (EMA/CVMP/SWP/104211/2023) for release for a 2-month period of public consultation. 
The Committee adopted a guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/SWP/32027/2022), to be released for a 4-month period of public consultation. 

Immunologicals 

The Committee adopted a guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets (EMA/CVMP/IWP/228730/2022), to be released for a 4-month period of public consultation.

The Committee adopted a guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/IWP/224724/2022), to be released for a 4-month period of public consultation.

Working parties 

The Committee re-elected Damien Bouchard as Vice-Chair of the Antimicrobials Working Party (AWP), for a 3-year mandate. 

The Committee re-elected Cristina Muñoz Madero as Chair of the Efficacy Working Party (EWP-V), for a 3-year mandate. 

The Committee elected James Mount as Chair of the Veterinary Pharmacovigilance Working Party (PhVWP-V), for a 3-year mandate. 

The Committee elected Sara Sacristan as CVMP Co-chair of the ESUAVet Working Group, for a 3-year mandate. 

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”.

1The meeting highlights have been updated on 5 October 2023; the information on eligibility according to Article 23 of Regulation (EU) 2019/6 for a product for ornamental birds, pet rabbits, rats, mice and reptiles was corrected to clarify that the product is eligible for authorisation under Article 23.

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