The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Nobilis Multriva IBm+ND, for the active immunisation of chickens for reduction of respiratory signs and egg drop caused by infectious bronchitis virus (IBV) strains Massachusetts (GI-1 genotype) and 4/91-793B (GI-13 genotype) and reduction of mortality and clinical signs caused by Newcastle disease virus (NDV).
The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Nobilis Multriva Gm+REOm for the active immunisation of chickens for passive immunisation of the progeny of the vaccinated chickens to reduce mortality and clinical signs of disease caused by very virulent (CS89) and classical (STC) strains of infectious bursal disease virus (IBDV), and to reduce viraemia and clinical signs of disease caused by avian reovirus (ARV) genotypes 1 and 4.
The Committee adopted by consensus a positive opinion for a marketing authorisation from CP-Pharma Handelsgesellschaft mbH for Emevet (maropitant), for the prevention of nausea induced by chemotherapy and the prevention of vomiting induced by motion sickness in dogs.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9/9.1 of the QRD template for:
The Committee was informed of the formal notification from TriviumVet of their decision to withdraw the application for an initial marketing authorisation for Sirolimus TriviumVet. More information about this application and the current 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 adopted three scientific advice reports and endorsed one clarification of a scientific advice report, of which one concerned a biological, one an immunological and two concerned pharmaceutical products. The target species were dogs (two products), honeybees (one product) and horses (one product).
Environmental Risk Assessment
The Committee adopted a draft concept paper on for the development of a reflection paper on the environmental risk assessment of antimicrobial resistance in the environment (EMA/CVMP/ERA/75412/2023) for release for a 6-month period of public consultation.
The Committee agreed to include dibutyl sebacate as a new entry in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients and adopted the revised list (EMA/CVMP/519714/2009-Rev. 59). This decision followed the Committee’s review of a request that had been submitted by an applicant in accordance with the relevant CVMP guidance.
The Committee elected Dr. Hanna Bremer as a new member of the Scientific Advice Working Party.
The Agency has revised its approach to the handling of Variations Not Requiring Assessment (VNRA) consequential to a Variation Requiring Assessment (VRA) for centrally authorised veterinary medicinal products.
When applying for a VRA, marketing authorisation holders may now choose to include related VNRA(s) as consequential changes within the application for the VRA. Further details will be available in an updated veterinary regulatory post-authorisation Q&A on VRAs which will be published shortly.
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”.