Nexgard Spectra

Authorised

This medicine is authorised for use in the European Union

afoxolaner / milbemycin oxime

Overview

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

Nexgard Spectra : EPAR - Medicine overview

Product information

Nexgard Spectra : EPAR - Product Information

Nexgard Spectra : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nexgard Spectra
• Active substance:
  • afoxolaner
  • milbemycin oxime
• International non-proprietary name (INN) or common name:
  • afoxolaner
  • milbemycin oxime

Pharmacotherapeutic group

• Endectocides
• Antiparasitic products, insecticides and repellents
• milbemycin oxime, combinations

Authorisation details

• EMA product number:
  EMEA/V/C/003842

Assessment history

Changes since initial authorisation of medicine

Nexgard Spectra : EPAR - Procedural steps taken and scientific information after authorisation

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

Adopted Reference Number: EMADOC-1700519818-2201538

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

Adopted Reference Number: EMA/CVMP/924541/2022

Nexgard Spectra-V-C-3842-II-0019: Assessment report - Variation

Adopted

Nexgard Spectra-V-C-3842-WS-1559 : Assessment report - Variation

Adopted

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

Adopted Reference Number: EMA/CVMP/369028/2019

CVMP post-authorisation summary of positive opinion for Nexgard Spectra (II-0019)

Adopted Reference Number: EMA/CVMP/369202/2019

Nexgard Spectra-V-C-3842-WS-1338-G : EPAR - Assessment report - Variation

CVMP post-authorisation summary of positive opinion for Nexgard Spectra

Adopted Reference Number: EMA/CVMP/525858/2018

Nexgard Spectra-V-C-3842-II-0008 : EPAR - Assessment Report - Variation

Adopted

Initial marketing authorisation documents

Nexgard Spectra : EPAR - Public assessment report

Adopted

CVMP summary of positive opinion for Nexgard Spectra

Adopted Reference Number: EMA/CVMP/641766/2014