Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-10 December 2020
CVMP recommends first monoclonal antibody medicine to manage osteoarthritis pain in cats
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Solensia (frunevetmab) from Zoetis Belgium SA, a new product for the alleviation of pain associated with osteoarthritis in cats, the first monoclonal antibody authorised for cats.
The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
- Circovac (grouped)
- Innovax-ILT (grouped)
- Galliprant (grouped)
Renewals of marketing authorisations
The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for Evalon and Letifend. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and therefore recommended the renewal of the marketing authorisations.
Community referrals and related procedures
The Committee concluded the referral procedure for Adjusol and its associated names (sulfadiazine and trimethoprim) from Virbac. The matter was referred to the Committee by the European Commission under Article 34 of Directive 2001/82/EC due to divergent decisions taken by Member States resulting in differences in the product information. The Committee agreed harmonised product information for the concerned products and 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 revise the current entry for propylene carbonate 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.48). This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.
The Committee adopted two separate scientific advice reports further to requests for initial advice, of which one concerned an immunological and one a pharmaceutical product. The target species for both products was dogs.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of one request for classification under the MUMS/limited market policy, the CVMP classified an indication for a product (ATCvet classification: Immunologicals) for dogs as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.
Following the Committee’s review of one re-examination request for classification under the MUMS/limited market policy, the CVMP classified a product for dogs (ATCvet classification: Genito-urinary system and sex hormones) as not indicated for MUMS/limited market and therefore not eligible for financial incentives.
Concept papers, guidelines and SOPs
The Committee adopted a reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation (EMA/CVMP/849775/2017). The reflection paper proposes non-experimental approaches for dose review, and for evaluating the consequences for withdrawal periods, target animal safety and environmental risk assessment. The objective is to facilitate the improvement of Summaries of Product Characteristics for established veterinary antibiotics in the EU in circumstances where new studies are not feasible. The comments received during the consultation procedure have been considered for the revision of the draft reflection paper and were also adopted for publication by the Committee.
Both documents, the reflection paper and the comments received during consultation, will be published on the Agency’s website.
The Committee reviewed the PSURs for Neptra and Vectra Felis, and recommended amendments to the product information.
The Committee also reviewed the PSURs for Bovela, Cortavance, Ecoporc Shiga, Gripovac 3, Isemid, Meloxidyl, Nasym, ProZinc, Syvazul BTV, Ubac and Velactis, and concluded that no further action or changes to their product information were required.
The Committee elected B. Kolar as vice-chair of the Environmental Risk Assessment Working Party for a 3-year mandate.
The Committee endorsed the work plans for 2021 for the CVMP Working Parties on Scientific Advice and Pharmacovigilance.
The Committee adopted guideline VICH GL59 on harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use following the sign-off by the VICH Steering Committee.
More information about the above-mentioned medicines, including their full indication, can be found below in “Related content”.