NexGard

Authorised

This medicine is authorised for use in the European Union

afoxolaner

Overview

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

NexGard : EPAR - Medicine overview

Product information

NexGard : EPAR - Product Information

NexGard : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

• Isoxazolines
• Ectoparasiticides for systemic use

Authorisation details

• EMA product number:
  EMEA/V/C/002729

Assessment history

Changes since initial authorisation of medicine

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

CVMP post-authorisation summary of positive opinion for NexGard (VRA0000245082)

Adopted Reference Number: EMADOC-1700519818-2201538

CVMP post-authorisation summary of positive opinion for NexGard (WS)

Adopted Reference Number: EMA/CVMP/924541/2022

NexGard-V-C-WS-1559 : EPAR - Assessment report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for NexGard Spectra ; NexGard

Adopted Reference Number: EMA/CVMP/369028/2019

NexGard-V-C-2729-WS-1338-G : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for NexGard (WS1338_G)

Adopted Reference Number: EMA/CVMP/525858/2018

Initial marketing authorisation documents

CVMP summary of positive opinion for NexGard

Adopted Reference Number: EMA/CVMP/700673/2013

NexGard : EPAR - Public assessment report

Adopted