Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-5 November 2020

CVMP recommends a new antiparasitic veterinary medicine for cats

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation application for NexGard Combo (esafoxolaner/eprinomectin/praziquantel) from Boehringer Ingelheim Vetmedica GmbH, a new spot-on solution for cats with or at risk from mixed infections by cestodes, nematodes and ectoparasites.

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Enteroporc Coli from IDT Biologika GmbH, a new vaccine for the active immunisation of pregnant gilts and sows to provide passive protection to piglets against porcine neonatal diarrhoea caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6.

The Committee adopted by consensus a positive opinion for a type II variation application for Advocate to update the product information as regards the use of the product during pregnancy and lactation.

The Committee adopted by consensus positive opinions for type II variation applications concerning quality related changes for:

• Clynav;
• Sevohale (grouped);
• Equilis Prequenza and Equilis Prequenza Te (subject to a worksharing procedure).

The Committee also adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure) for Respiporc FLU3, Ecoporc Shiga, Respiporc FLUpan H1N1 and Rabitec concerning quality-related changes.

Community referrals and related procedures

The Committee concluded the referral procedure for Valbazen oral suspension and associated names, including its generic/hybrid products which contain 100 mg or 200 mg albendazole per ml. The matter was referred to the Committee by Germany under Article 35 of Directive 2001/82/EC due to concerns relating to the appropriateness of the withdrawal periods in cattle. The Committee agreed that the withdrawal periods for milk, meat and offal derived from treated cattle should be amended to ensure consumer safety. The Committee adopted by consensus an opinion concluding that the marketing authorisations of the concerned products should be varied in order to amend the product information accordingly.

Maximum residue limits

The Committee agreed to update the entry for propylene carbonate on the list of substances considered as not falling within the scope of regulation (EC) No 470/2009 and adopted a revised list (EMA/CVMP/519714/2009–Rev.47). 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 seven separate scientific advice reports further to requests for initial advice of which two concerned immunological and five pharmaceutical products. The respective target species were cattle (three products), chickens, cats and dogs, dogs, and turkeys.

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of four requests for classification under the MUMS/limited market policy, the CVMP classified:

• A product (ATCvet classification: Musculoskeletal system) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives, as according to the MUMS policy products for horses are generally not eligible for fee incentives, and due to the existence of currently authorised alternative products in the EU.
• A product (ATCvet classification: Immunologicals) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives, as according to the MUMS policy products for horses are generally not eligible for fee incentives.
• A product (ATCvet classification: Antineoplastic and immunomodulating agents) for dogs as indicated for MUMS/limited market and not eligible for financial incentives.
• A product (ATCvet classification: Immunologicals) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives, as according to the MUMS policy products for horses are generally not eligible for fee incentives.

Pharmacovigilance

The Committee reviewed the PSURs for Bovilis Blue-8, Bravecto, Bravecto Plus, Mirataz and Vectra 3D, and concluded that no further action or changes to their product information were required.

More information about the above-mentioned medicines, including their full indication, can be found below in “Related content”.