Panacur AquaSol

Authorised

This medicine is authorised for use in the European Union

fenbendazole

Overview

This is a summary of the European public assessment report (EPAR) for Panacur AquaSol. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Panacur AquaSol.

For practical information about using Panacur AquaSol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Panacur AquaSol : EPAR - Summary for the public

Product information

Panacur AquaSol : EPAR - Product Information

Latest procedure affecting product information: II/0015

20/03/2018

Panacur AquaSol : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Panacur AquaSol
• Active substance:
  fenbendazole
• International non-proprietary name (INN) or common name:
  fenbendazole
• Species:
  • Pigs
  • Chicken
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP52AC13

Pharmacotherapeutic group

• Anthelmintics
• Benzimidazoles and related substances
• fenbendazole

Therapeutic indication

For the treatment and control of gastro-intestinal nematodes in pigs infected with:

• Ascaris suum (adult, intestinal and migrating larval stages);
• Oesophagostomum spp. (adult stages);
• Trichuris suis (adult stages).

For the treatment of gastro-intestinal nematodes in chickens infected with:

• Ascaridia galli (L5 and adult stages);
• Heterakis gallinarum (L5 and adult stages);

Capillaria spp. (L5 and adult stages).

Authorisation details

• EMA product number:
  EMEA/V/C/002008
• Marketing authorisation holder:
  Intervet International BV

  Wim de Körverstraat 35; 5831 AN Boxmeer; The Netherlands

• Marketing authorisation issued:
  09/12/2011
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Panacur AquaSol : EPAR - Procedural steps taken and scientific information after authorisation

Panacur AquaSol-V-C-2008-II-0015 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/73085/2018

CVMP post-authorisation summary of positive opinion for Panacur AquaSol (II/0015)

AdoptedReference Number: EMA/CVMP/834159/2017

Panacur AquaSol-V-C-2008-X-03 : EPAR - Assessment Report - Extension

AdoptedReference Number: EMA/42178/2014

CVMP post-authorisation summary of positive opinion for Panacur AquaSol

AdoptedReference Number: EMA/CVMP/735220/2013

Panacur AquaSol-V-C-2008-II-02 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/808903/2012

CVMP post-authorisation summary of positive opinion for Panacur AquaSol

Reference Number: EMA/CVMP/732988/2012

Initial marketing authorisation documents

Panacur AquaSol : EPAR - Public assessment report

AdoptedReference Number: EMA/834185/2011

CVMP summary of positive opinion for Panacur AquaSol

AdoptedReference Number: EMA/CVMP/760936/2011