PV Bulletin

Pharmacovigilance-related Recommendations for Bravecto (Fluralaner)

New safety warnings for Bravecto have been added following a July 2026 update, mandating immediate label changes.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

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.

Relevant for
Regulatory Intelligence LeadSignal Management LeadLabeling Lead
Processes impacted
LabelingSignal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Guideline
Policy status
revised
Publication date
2026-04-21
Last updated
2026-07-24
Policy change
This monthly updated procedural guideline provides CVMP-adopted recommendations for safety label changes for centrally authorized veterinary medicines. The July 2026 update incorporates new safety information and warnings resulting from pharmacovigilance signals and periodic reviews.

Key changes

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.

Affected workflows

LabelingSignal Management

Responsible groups

Regulatory AffairsPV Operations

PV impact

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.

View regulator source

Source document details

Exact policy details

Monthly Updates
Monthly updates of adopted outcomes of CVMP
Applies to: All centrally authorised veterinary medicinal products
This document is updated monthly with the adopted outcomes of the Committee for Veterinary Medicinal Products (CVMP). · p. 1 · High · Source
Report Submission
Reports should be sent to either the marketing authorisation holder or the national competent authority
Applies to: Veterinary medicinal product reporting
Reporting adverse events is important. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. · p. 6 · High · Source

Workflow rule impacts

Signal ManagementVeterinary Safety Officer

Additional training may be required for veterinarians to address new recommendations

Increased monitoring due to new adverse effects and recommendations

New recommendations require veterinarian caution in administration and consideration of adverse events. · p. 6 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jul 24, 2026

Full briefing

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.

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.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Guideline#revised#European Medicines Agency (EMA)#labeling#policy-change#firecrawl-policy-agent

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