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”.
Related content
Bravecto: EPAR
Galliprant: EPAR
Innovax-ILT: EPAR
Kriptazen: EPAR
Leucofeligen FeLV/RCP: EPAR
Masivet: EPAR
NexGard Combo: EPAR
Nobilis Influenza H5N2: EPAR
Porcilis PCV M Hyo: EPAR
Poulvac E. coli: EPAR
Prevomax: EPAR
Purevax Rabies: EPAR
Stronghold: EPAR
Suprelorin: EPAR
Versican Plus L4: EPAR
Versican Plus Pi: EPAR
Versican Plus Pi/L4: EPAR
Newflend ND H9: Pending EC decision
Bravecto: Withdrawn application
Leucofeligen FeLV/RCP: Pending EC decision
Bravecto: Pending EC decision
Suprelorin: Pending EC decision
Related content
Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 March 2023
CVMP: Agendas, minutes and reports
Source: EMM/ European Council