CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation for Prevexxion RN+HVT+IBD, from Boehringer Ingelheim Vetmedica GmbH, a live recombinant viral vaccine for the active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by Marek’s disease virus (including very virulent Marek’s disease virus), and to prevent mortality, clinical signs and lesions caused by infectious bursal disease virus.
The Committee adopted by consensus a positive opinion for a marketing authorisation for Prevexxion RN, from Boehringer Ingelheim Vetmedica GmbH, a live recombinant viral vaccine for the active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by Marek’s disease virus (including very virulent Marek’s disease virus).
The Committee adopted by majority a positive opinion for a type II variation application to add a new therapeutic indication for Aivlosin (tylvalosin) 625 mg/g granules for use in drinking water for pigs.
The Committee adopted by consensus a positive opinion for a type II variation application for Zulvac BTV in order to allow the use of the current monovalent vaccine against serotype 4 in cattle.
The Committee adopted by consensus a positive opinion for a type II variation application for Leucofeligen FeLV/RCP to change the onset of immunity for the calicivirus component of the vaccine to 3 weeks after first vaccine injection of primary vaccination.
The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
Reconcile;
Eryseng Parvo, Eryseng and Rhiniseng (worksharing procedure);
Purevax RC, Purevax RCP and Purevax RCPCH (grouped variation);
Purevax RCPCh FeLV, Purevax FeLV and Purevax RCP FeLV (grouped variation).
The Committee adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure) for Metacam and Novem (meloxicam) concerning the update of the SPC and the package leaflet following assessment of a PSUR.
More information about the above-mentioned medicines, including their full indication, will be published on the Agency’s website.
Renewals of marketing authorisations
The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for Fortekor Plus and Vectormune ND. 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 procedure for Suvaxyn PRRS MLV from Zoetis Belgium SA. The matter was referred to the Committee by the European Commission under Article 45 of Regulation (EC) No. 726/2004 due to concerns relating to animal health. Based on the available data, the Committee considered that there is no product-specific concern identified for Suvaxyn PRRS MLV. Risk mitigation measures were identified to decrease the risk of similar events occurring in the future. The Committee adopted by majority an opinion concluding that overall, the benefit-risk balance for Suvaxyn PRRS MLV is positive, subject to changes in the product information.
Scientific advice
The Committee adopted two scientific advice reports further to requests for:
Initial advice on efficacy issues for a new veterinary medicinal product for urinary system disorder in cats;
Initial advice on efficacy issues for a new immunological veterinary medicinal product for cattle.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of two requests for classification under the MUMS/limited market policy, the CVMP classified:
A product (alimentary tract and metabolism) 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.
A product (immunological) for salmon as not indicated for MUMS/limited market and not eligible for financial incentives.
Pharmacovigilance
The Committee reviewed the PSURs for Clynav, Draxxin, Halagon, Isemid, Porcilis ColiClos, Poulvac E. Coli, Syvazyl BTV and Vectra Felis, and concluded that no further action or changes to their product information were required.
The Committee adopted the revised combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA/CVMP/PhVWP/10418/2009-Rev.11) and the revised guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans (EMA/CVMP/PhVWP/288284/2007-Rev.12). The implementation of the VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for 1 October 2020.
The documents above will be published on the Agency’s website.
Regulatory
Further to the request from the European Commission, the Committee adopted two scientific advices with recommendations for implementing measures under Article 77(6) of Regulation (EU) 2019/6 on good pharmacovigilance practice and on pharmacovigilance system master files for veterinary medicinal products.
The documents will be sent to the European Commission and published on the Agency’s website in due course.
