Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021
News
Veterinary
Medicines
The Committee adopted by consensus a positive opinion for a marketing authorisation application for CircoMax (porcine circovirus vaccine (inactivated recombinant)), from Zoetis Belgium SA, a new vaccine for the active immunisation of pigs against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, virus faecal shedding and the lesions in lymphoid tissues associated with PCV2 infection.
The Committee adopted by consensus a positive opinion for a type II variation application for Respiporc FLUpan H1N1 (inactivated influenza A virus / human strain), from CEVA Santé Animale, concerning the amendment of the product information to allow the use during pregnancy and lactation.
The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
- Vaxxitek HVT+IBD and Bovela (work-sharing procedure)
- Halagon
- Credelio
The Committee adopted by consensus a positive opinion for a grouped type IB variation application (subject to a work-sharing procedure) for Oncept IL-2 (canarypox virus expressing feline interleukin-2, live), concerning quality-related changes.
Withdrawal of marketing authorisation
The Committee was informed of the formal notification from Prevtec Microbia GmbH of their decision to withdraw the marketing authorisation for Coliprotec F4 (EMEA/V/C/003797). Information about this withdrawal will be made available in a public assessment report, which will be published on the Agency’s website in due course.
Scientific advice
The Committee adopted one scientific advice report further to a request for initial advice, concerning a veterinary pharmaceutical product intended for dogs.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of one request for classification under the current MUMS/limited market policy, the CVMP classified a product (ATCvet classification: Immunologicals for domestic fowl) for ducks as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species and no alternative product for the same species is authorised in the EU.
Pharmacovigilance
The Committee reviewed the PSURs for Credelio Plus, Equilis West Nile, HorStem, Meloxoral, Mirataz, Nobivac Myxo RHD Plus, Prac-Tic and Vectra Felis, and concluded that no further action was required.
The Committee reviewed the PSUR for Librela and concluded that changes to its product information were required.
Regulation (EU) 2019/6
The Committee adopted the following documents related to Regulation (EU) 2019/6:
- Veterinary good pharmacovigilance practice modules on: collection and recording of suspected adverse events for veterinary medicinal products (EMA/306663/20201), signal management (EMA/522332/2021), veterinary pharmacovigilance communication (EMA/63454/2021), pharmacovigilance inspections (EMA/328998/2021), and pharmacovigilance systems and their pharmacovigilance systems master file and quality management system (EMA/595115/2021). The comments received during the public consultation phase where considered for the finalisation of the modules.
- A draft concept paper on the revision of the CVMP recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products for a 3-month period of public consultation (EMA/CVMP/299406/2021).
- A draft procedural advice document on veterinary vaccine antigen master file certification for a 2-month period of public consultation (EMA/127488/2021).
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”.