CVMP Meeting Highlights – September 2025

September 12, 2025 Lisa Park Tech
News Context
At a glance
  • Here's a breakdown of the key outcomes from the CVMP (Committee for Medicinal ‍Products for⁣ Veterinary Use) meeting, based on the provided text:
  • * Bravecto Triuna: Approved for treating⁣ Angiostrongylus vessels infections.
  • * Polyethylenimine: Added to the list of excipients not falling under Regulation (EC) No.
Original source: ema.europa.eu

Summary of CVMP Meeting Outcomes

Here’s a breakdown of the key outcomes from the CVMP (Committee for Medicinal ‍Products for⁣ Veterinary Use) meeting, based on the provided text:

1.Product Updates & Variations:

* Bravecto Triuna: Approved for treating⁣ Angiostrongylus vessels infections. Product data updated to align with QRD template version 9.1.
* Uncommon Adverse Events (Specific product Not Named): Decreased milk production, ‍reduced food intake, and decreased activity were added to the product information. instructions for allowing the vaccine to reach room temperature before use were also added.
* Quality-Related changes: Positive opinions were given for quality changes to: Arthricox, Btvpur, Credelio/Lotimax/AdTab/Credelio Plus, Cytopoint,‍ Draxxin, Easotic, Umayyad, Equable/Early prequenza, Equioxx, Felpreva, Prozinc, Renute, Semintra⁤ (x2), SENVELGO, Simparic trio,⁤ Strangvac, and Tulinovet.
* QRD Template Alignment: Product information for Chanhold, Evicto, Meloxidolor, News, Osurnia, Strangvac, Zulvac 1+8 Bovis, zulvac 1 + 8 Ovis, ‍and Zulvac SBV were updated to align with QRD template⁤ versions 9/9.1.

2. Maximum residue Limits:

* Polyethylenimine: Added to the list of excipients not falling under Regulation (EC) No. 470/2009.

3. Scientific Advice:

* Five scientific advice reports were adopted, covering products⁤ for dogs, horses, cats, and Atlantic⁤ salmon.These covered biological, immunological, and pharmaceutical products.

4. Limited⁣ Market Classifications (Article‍ 23 of Regulation (EU) ‍2019/6):

* Dog Product (Antineoplastic/Immunomodulating): Classified as limited market & eligible for Article 23 authorisation.
* Pig‍ Product (Immunologicals): Not classified as limited market & not eligible for Article 23 authorisation.
* Horse Product (Alimentary/Metabolism): Classified as limited market & eligible for Article 23 authorisation.

5. Guidelines:

* Immunologicals/BVDV Contamination: ⁤A guideline on handling ‍potential bovine viral diarrhoea ‍virus (BVDV) contamination in vaccines was revised for administrative updates and⁢ alignment with Regulation (EU) 2019/6.

In essence, the meeting ⁤focused on approving changes to existing veterinary medicines, clarifying regulatory status of certain substances, providing scientific guidance for new product development, and updating guidelines for vaccine safety.