Meeting highlights from the Committee for Veterinary Medicin…

CVMP opinions on veterinary medicinal products 

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Alcort (hydrocortisole aceponate), from Nextmune Italy S.r.l., a new product for the alleviation of clinical signs associated with atopic dermatitis and for symptomatic treatment of inflammatory and pruritic dermatoses in dogs. 

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Lexylan (cephalexin sodium), from Emdoka, a new generic product for the treatment of metritis, interdigital dermatitis, wounds and abcesses, treatment of septicemic mastitis in addition of an intramammary therapy, in cattle; infections of the respiratory tract, the uro-genital system, the skin, soft tissues and the gastro-intestinal system, in dogs, and Infections of the respiratory tract, the uro-genital system, the skin and soft tissues, in cats. 

The Committee adopted by consensus a positive opinion for a marketing authorisation Divence Penta from LABORATORIOS HIPRA, S.A., a new vaccine for the active immunisation of cattle from 10 weeks of age to reduce virus shedding, hyperthermia, clinical signs and lung lesions caused by bovine respiratory syncytial virus and parainfluenza virus 3; to reduce virus shedding, hyperthermia and clinical signs caused by infectious bovine rhinotracheitis virus; to reduce viremia, hyperthermia and leukopenia caused by bovine viral diarrhoea virus 1 and bovine viral diarrhoea virus 2 and virus shedding caused by bovine viral diarrhoea virus 2; and for the active immunisation of heifers and cows to reduce births of persistently infected calves and transplacental infection of bovine viral diarrhoea virus (type 1 and 2).

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac 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 Credelio, AdTab (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 positive opinions for variations requiring assessment concerning quality-related changes for:

• Aivlosin
• Bovela (grouped)
• Daxocox
• Gumbohatch (grouped)
• Increxxa
• Librela (grouped)
• Profender
• Syvazul BTV (2 procedures)

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:

• Draxxin
• Incurin
• Lydaxx
• Ovugel
• Purevax RCP, Purevax RCP FeLV (subject to worksharing)
• Suprelorin
• Syvazul BTV 
• Tulissin

Scientific advice

The Committee adopted three scientific advice reports further to requests for initial advice, concerning one biological product and two immunological products. The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).

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

Following a request, the CVMP classified:

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

Concept papers, guidelines

Quality

The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.

The comments received during the consultation procedure were taken into account for the revision of the annex.
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”.