Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-12 February 2025

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation from Ceva Santé Animale for Vectormune HVT-AIV for active immunisation of one-day-old chickens to reduce mortality, clinical signs, and virus excretion due to infection with highly pathogenic avian influenza (HPAI) virus of the H5 sub-type.

The Committee adopted by majority a positive opinion for a marketing authorisation application from TriviumVet DAC for Omeprazole TriviumVet (omeprazole) as an aid in the treatment of non-steroidal anti-inflammatory drug (NSAID)-induced gastric ulceration in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation application from Elanco GmbH for Elmaro (maropitant citrate monohydrate) for the treatment and prevention of nausea and vomiting in dogs and cats.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Innovax-ND-H5 concerning fulfilment of two outstanding specific obligations as agreed during the granting of the marketing authorisation under exceptional circumstances.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Simparica Trio concerning change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment.

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

• Bluevac BTV
• Porcilis ColiClos (grouped)
• Strangvac (grouped)
• Suvaxyn PRRS MLV (grouped)

The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 or version 9.1 of the QRD template for:

• Cardalis
• Clevor
• Fortekor Plus
• Hydrocortisone aceponate Ecuphar
• Increxxa
• Ingelvac CircoFLEX
• Prozinc
• ReproCyc ParvoFLEX
• Sileo
• Sedadex

Maximum residue limits

The Committee adopted by consensus a positive opinion recommending the establishment of maximum residue limits for fluralaner in finfish. Fluralaner is currently included in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with numerical MRLs established for poultry and this CVMP opinion concludes positively on extrapolating these existing MRLs to finfish.

The Committee agreed to include polyethylene as a new entry in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients and adopted a revised list (EMA/CVMP/519714/2009-Rev. 58). This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.

Scientific advice

The Committee adopted one scientific advice report further to a request for an advice concerning a biological product, and endorsed a clarification of a previously given scientific advice for another biological product. The respective target species were dogs and cattle.

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

Following two requests, the CVMP classified:

• A product (ATCvet classification: Blood and blood forming organs) for cats as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
• A product (ATCvet classification: Immunologicals) for dogsas intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers and guidelines

Efficacy

The Committee adopted the revised guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/627/2001) and the revised guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA/CVMP/344/1999) together with the respective overviews of comments received on the draft revised guidelines during public consultation (EMA/CVMP/EWP/377613/2024), (EMA/CVMP/EWP/497046/2024). These revisions align the guidelines with the provisions of Regulation (EU) 2019/6.

Legislation

The Committee adopted a review of additional evidence provided for a substance with regard to the scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products – ‘list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months’. The recommendation adopted by the Committee in July 2024 was not modified.

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”.