Primary source: European Medicines Agency (EMA)
Updates to the Summary of Product Characteristics (SPC) and Package Leaflet (PL) for Bravecto, requiring immediate adaptations including specific precautions against hypersensitivity reactions in humans and potential injection site reactions in dogs.
These updated recommendations underscore essential safety measures for veterinarians and inform marketing authorisation holders of the critical need to adapt product information to prevent adverse events.
Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
New safety warnings added for fluralaner (Bravecto) regarding human hypersensitivity and injection site reactions in dogs; updates to product labels (SPC/PL) across several veterinary products based on CVMP outcomes.
MAHs for the affected products must update their Product Information (SPC and Package Leaflet) in accordance with the monthly CVMP recommendations. This involves labeling updates and ensuring local affiliates are informed of the new safety instructions.
Additional training may be required for veterinarians to address new recommendations
Increased monitoring due to new adverse effects and recommendations
Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.
The European Medicines Agency has updated the labeling requirements for centrally authorised veterinary medicinal products, specifically highlighting new safety warnings related to the veterinary product Bravecto, which involves heightened caution for human hypersensitivity and injection site reactions.
What changed: Updates to the Summary of Product Characteristics (SPC) and Package Leaflet (PL) for Bravecto, requiring immediate adaptations including specific precautions against hypersensitivity reactions in humans and potential injection site reactions in dogs.
Why it matters: These updated recommendations underscore essential safety measures for veterinarians and inform marketing authorisation holders of the critical need to adapt product information to prevent adverse events.
Practical implication: Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.
Published from the Firecrawl policy change extraction pipeline.
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