Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 September 2024
News
Veterinary
Medicines
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation application for ArthriCox (firocoxib), from Chanelle Pharmaceuticals Manufacturing Ltd, a new product for the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs and for the relief of pain and inflammation associated with osteoarthritis in dogs.
The Committee adopted by consensus positive opinion for a marketing authorisation Cirbloc M Hyo, from Ceva-Phylaxia Co. Ltd., a new vaccine for the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, the severity of lung lesions caused by Mycoplasma hyopneumoniae infection, and to reduce the loss in body weight gain.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for NexGard Combo (esafoxolaner/eprinomectin/praziquantel) to implement changes in the product information to further clarify the method of administration.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Yurvac RHD to add a new therapeutic indication: for passive immunisation against RHDV2 (not demonstrated against highly virulent strains) of the offspring of the vaccinated does for at least 30 days
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Cerenia
- Locatim
- Mhyosphere PCV ID (grouped)
- Panacur AquaSol (grouped)
- Profender (grouped)
- Respiporc FLU3 (grouped)
- Simparica, Simparica Trio (worksharing)
- Solensia
- Strangvac (grouped)
- Suvaxyn PRRS MLV (grouped)
- Zenalpha
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:
- Cimalgex
- Equilis West Nile
- Felpreva
- Inflacam
- Letifend
- Metacam
- Purevax FeLV
- Respiporc FLU3
- Rheumocam
- Novem
Withdrawal of applications
The Committee was informed of the formal notification from Intervet International B.V. of their decision to withdraw the application for an initial marketing authorisation for Equilis EHV 1+4. More information on the scientific assessment at the time of the withdrawal will subsequently be made available in the European public assessment report (EPAR). The EPAR together with the withdrawal letter from the applicant will be published on the Agency’s website in due course.
The Committee was informed of the formal notification from Elanco GmbH of their decision to withdraw the application for a variation requiring assessment concerning quality-related changes for Neptra.
Scientific advice
The Committee adopted a scientific advice report, further to a request for initial advice for a pharmaceutical product for horses.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following five requests, the CVMP classified:
- A product (ATCvet classification: immunologicals)for honey bees as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: immunologicals) for sea bass as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: immunologicals) for dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: alimentary tract and metabolism) for cats as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: to be confirmed) for exotic animals was deferred.
Concept papers and guidelines
Quality
The Committee adopted a draft guideline on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/426245/2023) for release for a 4-month period of public consultation. This guideline has been developed to provide recommendations on how the risk management may be conducted for elemental impurities for veterinary medicinal products (VMPs) authorised or to be authorised in the European Union in order to comply with the requirement of the European Pharmacopeia (Ph. Eur.) General Monograph 2619 for Pharmaceutical Preparations.
Legislation
The Committee adopted an administrative revision of the following guidelines to align them with the European Commission’s Guidance to Applicants:
- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6,
- Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6,
- Guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets applications submitted under Article 23 of the Regulation (EU) 2019/6.
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”.