The Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Vaxxinact H5 (Avian influenza vaccine (subunit recombinant)) intended for the following indications associated with highly pathogenic avian influenza (HPAI) serotype 5, including the circulating clade 2.3.4.4b:
The Committee adopted a positive opinion for a marketing authorisation for Ecovaxxin MS (Mycoplasma synoviae vaccine) for the active immunisation of future layer and future breeder chickens from 4 weeks of age to reduce air sac lesions, foot pad lesions (synovitis), ovarian regressions and egg production losses caused by Mycoplasma synoviae infections.
The Committee adopted a positive opinion for a variation for Frontpro (afoxolaner) concerning change(s) to therapeutic indication(s):
The Committee adopted a positive opinion for a variation following a work-sharing procedure for Credelio (lotilaner), Lotimax (lotilaner), Credelio Plus (lotilaner / milbemycin oxime) concerning change(s) to therapeutic indication(s) in dogs:
The Committee adopted a positive opinion for a variation for Mhyosphere PCV ID (Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)) intended to introduce some quality-related (manufacturing) changes and to update the product information to upgrade ‘Elevated body temperature’ from common to very common adverse events.
The Committee adopted, a positive opinion for a variation for Librela (bedinvetmab) to implement the outcome of the MAH’s signal management process to include ‘Diarrhoea’ and ‘Emesis’ as rare adverse events and ‘Immune-mediated polyarthritis’, ‘Paresis’, ‘Paralysis’ and ‘Seizure’ as very rare adverse events in the product information. In addition, warnings were introduced when treating dogs with pre-existing immune-mediated conditions and pre-existing seizure disorder. Furthermore, the product shelf-life was extended from 2 to 3 years.
The Committee adopted positive opinions for variations concerning quality-related (manufacturing) changes for:
The Committee adopted positive opinions for variations to align the product information with version 9.1 of the QRD template for:
The Committee started a procedure to provide scientific advice on veterinary medicinal products (VMPs) containing amoxicillin (as a single active substance) in pigs for use in drinking water or in feed, for respiratory indications. This procedure initiates the first exercise of the CVMP’s project on Dosage Review and Adjustment of established veterinary Antibiotics (ADRA), which aims to minimise antimicrobial resistance while safeguarding the availability of first-line treatment veterinary antibiotics in the European Union. The CVMP intends to review and refine the dosage regimen in the product information (PI) of the above-mentioned VMPs. This includes due consideration of the implications that a change in the dosage regimen of a VMP might have for target animal safety and, in the case of food-producing species, for the withdrawal period, as well as for the environmental risk assessment. The CVMP invites all stakeholders (e.g. marketing authorisation holders, veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure. Further details, including guidance on the submission of data and relevant timelines, are available on the dedicated procedure webpage.
The Committee was informed of the formal notification from BCN Peptides of their decision to withdraw the application for an initial marketing authorisation for Abantide BCN Peptides. More information about this application and the state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The document, together with the withdrawal letter from the applicant, will be published on the Agency’s website in due course.
The Committee agreed to include sulfobutyl ether Beta-cyclodextrin sodium (SBECD) and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (PCL-PVAc-PE) as new entries in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of “excipients”. This decision followed the Committee’s review of requests that had been submitted in accordance with the relevant CVMP guidance.
The Committee adopted three scientific advice reports following initial requests for one pharmaceutical and two biological products for dogs (2) and cats (1).
Following five requests, the CVMP classified:
The Committee adopted the outcomes of the signal management process. The signals submitted by marketing authorisation holders are listed, in chronological order, in the IRIS public portal: List of signals from Veterinary Signal Management · IRIS In order to access the list, the following filter should be applied in the ‘Submission type’ category: ‘Signal management submission’.
The Committee adopted the concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species.
The Committee adopted the questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets).
The Committee elected, unanimously, Irene de la Casa as vice-chair of the Environmental Risk Assessment Working Party for a 3-year mandate.
The Committee elected, unanimously, Damien Bouchard as chair of the temporary Working Party on Dosage Review and Adjustment of established Antibiotics for a 3-year mandate.
The Committee adopted the 2023-2024 3RsWP Biennial Report.
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”.