Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024

The Committee adopted by consensus a positive opinion for a marketing authorisation for DIVENCE IBR Marker Live from Laboratorios Hipra, S.A., a new vaccine intended for the active immunisation of cattle from 10 weeks of age to reduce virus shedding, hyperthermia and clinical signs caused by bovine herpesvirus type 1 (BoHV-1).

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Rabitec (rabies vaccine (live, oral)) to add a new strength for dogs as a new target species, with a new composition of the bait and new vaccine container within the bait specifically for dogs.

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Suvaxyn PRRS MLV (porcine respiratory and reproductive syndrome virus vaccine (live)) to change the product information relating to use in lactating sows and consequential adverse events in this category of animals, as well as to align the product information with version 9.0 of the QRD template.

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Daxocox (enflicoxib) to add two new tablet strengths (140 and 200 mg) and to amend the dosing table for the currently approved tablet strengths (15, 30, 45, 70 and 100 mg).

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Credelio, AdTab (lotilaner) (subject to worksharing procedure) to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Stronghold Plus (selamectin / sarolaner) to add a new therapeutic indication for the treatment of notoedric mange (Notoedres cati).

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Neptra (florfenicol / terbinafine hydrochloride / mometasone furoate) 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:

• Exzolt
• Ingelvac CircoFLEX
• Leucofeligen FeLV/RCP, Leucogen, Nobivac LeuFel (worksharing procedure)
• MS-H Vaccine (grouped)
• Panacur AquaSol (grouped)
• Prevexxion RN, Vaxxitek HVT+IBD, Prevexxion RN+HVT, Prevexxion RN+HVT+IBD (worksharing procedure)
• Proteq West Nile, Oncept IL-2, Prevexxion RN, ProteqFlu-Te, ProteqFlu, Purevax RCPCh FeLV, Purevax RC, Vaxxitek HVT+IBD, Purevax RCPCh, Purevax RCP FeLV, Purevax FeLV, Prevexxion RN+HVT, Prevexxion RN+HVT+IBD, Purevax RCP, Purevax Rabies (worksharing procedure)

Scientific advice

The Committee adopted four scientific advice reports concerning three biological products and a pharmaceutical product. The respective target species were dogs and cattle (two products each).

Concept papers and guidelines

Efficacy

The Committee adopted a revised guideline on demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/627/2001-Rev.2) for a 4-month period of public consultation. This guideline provides recommendations for the design and conduct of pre-clinical studies and clinical trials for veterinary medicinal products containing antimicrobial substances. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.

The Committee adopted a draft revised guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA/CVMP/344/1999-Rev.3) for a 4-month period of public consultation. This guideline provides guidance on design, conduct and reporting of pre-clinical studies and clinical trials or veterinary medicinal products for intramammary use in dairy cattle. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.

Regulatory matters

The Committee adopted a question and answer (Q&A) document on product classification (EMA/CVMP/93401/2024). This Q&A was developed to provide stakeholders with general clarifications on whether a veterinary medicinal product (VMP) is classified as a ‘non-biological VMP’, a ‘biological VMP other than immunological VMP’, or an ‘immunological VMP’, as well as reflections on whether a VMP can be considered as a novel therapy product.

Working parties

The Committee elected Boudewijn Catry as vice-chair of the Antimicrobials Working Party 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”.