Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March 2024
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Medicines
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation for Divence Tetra from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of cattle against bovine respiratory syncytial virus and parainfluenza-3 virus to reduce virus shedding, hyperthermia, clinical signs and lung lesions and against bovine viral diarrhoea virus (BVDV type 1 and 2) to reduce viremia, hyperthermia and leukopenia caused by BVDV-1 and BVDV-2 and virus shedding caused by BVDV-2; and for active immunisation of heifers and cows to reduce births of persistently infected calves and transplacental infection of BVDV (type 1 and 2).
The Committee adopted by consensus positive opinions for marketing authorisation applications for Trilocur (trilostane), from Emdoka, and Trilorale (trilostane), from Axience; both hybrid marketing authorisation applications of the decentralised reference product Vetoryl as products for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease and syndrome) in dogs.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS from Intervet International B.V., a new vaccine for the active immunisation of chickens for reduction of egg drop caused by avian metapneumovirus, reduction of respiratory signs and egg drop caused by infectious bronchitis virus, reduction of mortality and clinical signs caused by Newcastle disease virus, passive immunisation of the progeny of the vaccinated chickens to reduce mortality and clinical signs of disease caused by very virulent strains of infectious bursal disease virus (IBDV) and to reduce viraemia and clinical signs of disease caused by avian reovirus, and reduction of egg drop and eggshell defects caused by egg drop syndrome virus.
In the context of this marketing authorisation application, the Committee endorsed the first EMA certificates for vaccine antigen master files (VAMFs).
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Lotimax (lotilaner), from Elanco GmbH, a new product (informed consent of Credelio) for the treatment of flea and tick infestations and demodicosis (caused by Demodex canis) in dogs.
The Committee adopted by consensus a positive opinion for a variation requiring assessment concerning the addition of in ovo as a new route of administration for Prevexxion RN+HVT+IBD.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Respiporc FLUpan H1N1 (grouped)
- Senvelgo
- Bovela
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:
- Aivlosin (grouped) - including the addition of information to section 4.7 of the SPC and section 12 of the package leaflet on use during pregnancy, lactation or lay
- Coliprotec F4/F18
- Eurican Herpes 205
- Halocur - including the implementation of the ATCvet code change for halofuginone
- Nobilis IB Primo QX
- Purevax RCP
- Purevax RCP FeLV
- Respiporc FluPan H1N1
- Suiseng Diff/A
- Tulaven
- Zulvac BTV
Scientific advice
The Committee adopted four scientific advice reports further to requests for initial advice, and endorsed one clarification. The scientific advice requests concerned one immunological product for dogs, one immunological product for cattle and sheep, one pharmaceutical product for cats and one pharmaceutical product for dogs and cats; the clarification concerned a pharmaceutical product for dogs.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following one request, the CVMP classified:
- A product (ATCvet classification: Immunologicals) for wild boars as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Working parties
The Committee endorsed a survey on novel therapies to stakeholders that intends to map the development or intentions of development of novel therapies/innovative veterinary medicinal products (VMP) as well as the main hurdles for the development and authorisation of these products.
The Committee re-elected J. Poot as chair of the NTWP for a further 3-year mandate.
The Committee re-elected S. Casado as vice-chair of the NTWP for a further 3-year mandate.
International harmonisation
The Committee adopted VICH GL61 on Pharmaceutical Development for release for 5 months of public consultation.
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'.