Bravecto

Authorised

This medicine is authorised for use in the European Union

fluralaner

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Bravecto : EPAR - Medicine overview

Reference Number: EMA/783442/2014

Product information

Bravecto : EPAR - Product Information

Bravecto : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Bravecto
• Active substance:
  fluralaner
• International non-proprietary name (INN) or common name:
  fluralaner

Pharmacotherapeutic group

• Ectoparasiticides for systemic use
• Isoxazolines

Authorisation details

• EMA product number:
  EMEA/V/C/002526

Assessment history

Changes since initial authorisation of medicine

Bravecto : EPAR - Procedural steps taken and scientific information after authorisation

CVMP post-authorisation summary of positive opinion for Bravecto (VRA-0059)

CVMP post-authorisation summary of positive opinion for Bravecto (II-0054-G)

Adopted Reference Number: EMA/CVMP/294601/2022

Bravecto-V-C-2526-II-0051 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Bravecto (II-0051)

Adopted Reference Number: EMA/CVMP/696735/2021

Bravecto-V-C-2526-II-0036 : EPAR - Assessment Report - Variation

Adopted

Bravecto-V-C-2526-II-0033-G : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Bravecto (II/0033/G, II/0036)

Adopted Reference Number: EMA/CVMP/465180/2019

Bravecto-V-C-2526-X-0005 : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Bravecto

Adopted Reference Number: EMA/CVMP/186144/2016

Initial marketing authorisation documents

Bravecto : EPAR - Public assessment report

Adopted

CVMP summary of positive opinion for Bravecto

Adopted Reference Number: EMA/CVMP/627638/2013