Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
News
Veterinary
Medicines
CVMP opinions on veterinary medicinal products
Under Regulation (EC) No 726/2004
The Committee adopted by consensus a positive opinion for a marketing authorisation of Newflend ND H9, from Ceva-Phylaxia Co. Ltd., a new vaccine for the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs against Newcastle disease and H9 low pathogenic avian influenza.
Under Regulation (EU) 2019/6
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Bravecto
- Kriptazen
- Leucofeligen FeLV/RCP
- Masivet
- Nexgard Combo
- Prevomax
- Suprelorin
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:
- Bravecto
- Innovax-ILT
- Nobilis Influenza H5N2
- Porcilis PCV M Hyo
- Poulvac E. coli
- Purevax Rabies
- Stronghold
- Versican Plus L4
- Versican Plus Pi
- Versican Plus Pi/L4
Scientific advice
The Committee adopted 4 scientific advice reports further to requests for initial advice concerning two biological products, one immunological product, and one pharmaceutical product. The respective target species (one product each) were cattle, dogs, salmon, and horses.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following 2 requests, the CVMP classified:
- A product (ATCvet classification: Alimentary tract and metabolism) for cats and dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Nervous system) for dogs as not intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Pharmacovigilance
Under Regulation (EU) 2019/6
The Committee adopted a recommendation for changes to the summary of product characteristics for Galliprant as an outcome of signal management activities.
Concept papers, guidelines and SOPs
Pharmacovigilance
The Committee adopted revised questions and answers on describing adverse events in the product information (summary of product characteristics and package leaflet; EMA/CVMP/150343/2016-Rev.3), which is also relevant for variations requiring assessment to align product information with version 9.0 of the QRD template.
Quality
The Committee adopted an Annex to the Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products, for a 3-month period of public consultation.
More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews of comments received during consultation, can be found below in “Related content”.