Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023
CVMP opinions on veterinary medicinal products
The Committee adopted, by consensus, a positive opinion for a marketing authorisation application for Prolevare, an informed consent application, from Zoetis Belgium, a new product for the treatment of pruritus associated with allergic dermatitis in dogs and treatment of clinical manifestations of atopic dermatitis in dogs1.
Under Regulation (EU) 2019/6
The Committee adopted by consensus positive opinions for variation requiring assessment to align the product information with version 9.0 of the QRD template for:
- Bravecto Plus - grouped procedure including addition of a new therapeutic indication for the prevention of aelurostrongylosis (by preventing the establishment of adult Aelurostrongylus abstrusus responsible for clinical disease)
- Zeleris - grouped procedure including addition of a new therapeutic indication for the treatment of bovine respiratory disease due to Mycoplasma bovis associated with pyrexia
- Aservo EquiHaler – grouped procedure including update of the package leaflet sections on special precautions for use, following the outcome of the CVMP assessment of the PSUR
- Simparica Trio
- Librela - grouped procedure including update of the SPC and package leaflet sections on special precautions for use and adverse events, following the outcome of the CVMP assessment of the 3rd PSUR
- Gumbohatch - grouped procedure including addition of a mixed, associated use of Gumbohatch and Evanovo
- BTVPUR - grouped procedure including amendment of the SPC and package leaflet sections on adverse events, as recommended based on signal detection activities.
The Committee adopted by consensus a positive opinion for variations requiring assessment for concerning quality-related changes for:
- Mhyosphere PCV ID
- Syvazul BTV (grouped)
- Equip WNV
- Purevax RCP FeLV, Purevax RCP (subject to a worksharing procedure)
- Suvaxyn PRRS MLV
- Equip WNV (2 procedures)
- Versican Plus Pi/L4R; Versican Plus Pi/L4; Versican Plus DHPPi/L4; Versican Plus DHPPi/L4R; Versican Plus L4 (subject to a worksharing procedure)
- Vectormune FP ILT; Vectormune FP ILT + AE (subject to a worksharing procedure)
The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Suvaxyn PRRS MLV concerning the addition of nasal use as an additional route of administration and to modify the approved therapeutic indication to include protection against heterologous subtype-1 AUT15-33, subtype-2 BOR57 and subtype-3 Lena strains of the PRRS virus.
The Committee adopted by majority a positive opinion for a variation requiring assessment for Lotilaner Elanco (lotilaner) concerning the change of classification from ‘subject to veterinary prescription’ to ‘not subject to veterinary prescription’.
Under Regulation (EC) No 726/2004
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Bovilis Nasalgen-C, from Intervet International B.V., a new vaccine for the active immunisation of cattle from the day of birth onwards to reduce clinical signs of upper respiratory tract disease and nasal viral shedding from infection with bovine coronavirus.
The Committee adopted by consensus a positive opinion for an extension application of the existing marketing authorisation for Coxevac (Coxiella burnetii vaccine (inactivated)), from CEVA Santé Animale, concerning the addition of a new target species: sheep.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Innovax-ILT-IBD (Marek's disease, avian infectious laryngotracheitis and infectious bursal disease vaccine (live recombinant)), from Intervet International B.V., a new vaccine for the active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus and to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus.
The Committee adopted, by consensus, a positive opinion for a marketing authorisation application for Eurican L4 (canine leptospirosis vaccine), from Boehringer Ingelheim Vetmedica GmbH, a new vaccine for the active immunisation of dogs from 7 weeks of age to prevent or reduce mortality, clinical signs, infection, bacterial excretion, renal carriage and renal lesions due to canine leptospirosis.
Union referrals and related procedures
The Committee concluded two referral procedures for Catophos 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names and Vey Tosal 100mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names (both containing butafosfan and cyanocobalamin (vitamin B12)) from CP-Pharma Handelsgesellschaft mbH and Veyx-Pharma GmbH, respectively. The matters were referred to the Committee by Czechia as the reference Member State in the decentralised procedures, under Article 33(4) of Directive 2001/82/EC due to concerns raised by Germany in relation to bioequivalence for the intramuscular and subcutaneous routes of administration.2The Committee adopted by consensus the opinions concluding that the objections raised by Germany during the decentralised procedure should not prevent the granting of the marketing authorisations for the above-mentioned veterinary medicinal products.
The Committee adopted five scientific advice reports further to four requests for initial advice and one follow-up advice. One request concerned a biological product and four concerned pharmaceutical products. The respective target species were dogs, horses, sheep and cattle.
Concept papers, guidelines and SOPs
The Committee adopted a draft guideline on plasmid DNA vaccines for veterinary use (EMA/CVMP/IWP/365817/2022) for a 4-month period of public consultation. This guideline has been developed to provide advice to manufacturers seeking marketing authorisation for nucleic acid vaccines for use in animals when the vaccine consists of (a) bacterial or a synthetic DNA plasmid(s). It applies to DNA vaccines - consisting of plasmid DNA non-amplifiable in eukaryotic cells.
The CVMP meeting was followed by a European Medicines Agency Info Day on 16-17 February 2023 under the theme “Updates on regulatory policy, scientific and procedural developments”.
The Committee adopted two revised VICH pharmacoviligance guidelines:
- GL35 on IT systems: Pharmacovigilance: electronic standards for transfer of data
- GL42 on IT systems: Pharmacovigilance: data elements for submission of adverse event reports
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 under 'Related content'.
1The information on the positive opinion for marketing authorisation application for Prolevare was corrected on 24 March 2023 to clarify that the product was adopted under Regulation (EU) 2019/6.
2 The information on the two referral procedures for Catophos 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names and Vey Tosal 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names was corrected on 10 March 2023 to reflect that the correct scope of the procedure is bioequivalence for the intramuscular and subcutaneous routes of administration (and not safety and efficacy as stated on 17 February 2023).
- Aservo EquiHaler: EPAR
- Bravecto Plus: EPAR
- BTVPUR: EPAR
- Coxevac: EPAR
- Equip WNV (previously Duvaxyn WNV): EPAR
- Galliprant: EPAR
- Gumbohatch: EPAR
- Halocur: EPAR
- Innovax-ND-IBD: EPAR
- Librela: EPAR
- Mhyosphere PCV ID: EPAR
- Naxcel: EPAR
- Procox: EPAR
- Purevax RCP FeLV: EPAR
- Simparica Trio: EPAR
- Suprelorin: EPAR
- Suvaxyn PRRS MLV: EPAR
- Syvazul BTV: EPAR
- Trocoxil: EPAR
- Vectormune FP ILT: EPAR
- Vectormune FP ILT + AE: EPAR
- Versican Plus DHPPi/L4: EPAR
- Versican Plus DHPPi/L4R: EPAR
- Versican Plus L4: EPAR
- Versican Plus Pi/L4: EPAR
- Versican Plus Pi/L4R: EPAR
- Zeleris: EPAR
- Zolvix: EPAR