Equioxx

firocoxib

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Equioxx.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 Equioxx.

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

What is Equioxx and what is it used for?

Equioxx is a medicine used in horses to relieve pain and inflammation in the joints caused by osteoarthritis (a long-term disease causing damage and pain in the joints) and to reduce the lameness that is associated with the disease. It contains the active substance firocoxib.

How is Equioxx used?

Equioxx is available as a solution for injection, an oral paste and chewable tablets. Treatment is once daily. The solution for injection is given into a vein while the paste and tablets are given by mouth. The dose depends on the bodyweight of the animal except for the tablets which are for horses of 450 to 600 kg bodyweight and where the dose is one tablet. The overall duration of treatment depends on the horse’s response, but should not exceed 14 days. Equioxx can only be obtained with a prescription.

How does Equioxx work?

The active substance in Equioxx, firocoxib, is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oygenase-s (COX-2) inhibitors’ (or Coxibs). It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins, Equioxx helps reduce the responses of inflammation, including pain.

What benefits of Equioxx have been shown in studies?

Two field studies investigated the effectiveness of Equioxx oral paste in treating horses with lameness of more than 4 weeks due to osteoarthritis. One study in the USA compared Equioxx to another NSAID medicine, phenylbutazone, and the second study in Europe compared Equioxx to the NSAID vedaprofen. The studies showed that Equioxx oral paste given daily for 14 days was as effective as the comparator medicines.

Equioxx oral paste and Equioxx solution for injection have been studied in a laboratory and found to be bioequivalent. Similarly Equioxx oral paste and Equioxx chewable tablets have been shown to be bioequivalent. Two forms of a medicine are bioequivalent when they produce the same levels of active substance in the body. This means that the solution for injection and the chewable tablets can be expected to produce similar results to the oral paste.

What are the risks associated with Equioxx?

The most common side effects with Equioxx (which may affect more than 1 in 10 horses) are ulcers or sores of the lining of the mouth or the skin around the mouth. These are typically mild and resolve without treatment.

The most common side effects with Equioxx (which may affect up to 1 in 100 horses) are salivation and lip and tongue swelling associated with the mouth sores.

Equioxx must not be used in horses suffering from stomach or gut disorders and bleeding, nor in case of reduced liver, heart or kidney function or bleeding disorders.

Equioxx must not be used in breeding, pregnant or lactating horses.

Equioxx must not be used at the same time as corticosteroid medicines or other NSAIDs.

For the full list of all side effects reported with Equioxx and the full list of restrictions, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for Equioxx, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

People should avoid contact of the medicine with eyes and skin and wash their hands after handling the product.

Women of child-bearing age should avoid contact with, or wear disposable gloves, when giving the product.

If the medicine is accidentally swallowed or someone accidentally injects themselves, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from horses treated with Equioxx is 26 days.

The medicine is not authorised for use in horses producing milk for human consumption.

Why is Equioxx approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Equioxx’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Equioxx:

The European Commission granted a marketing authorisation valid throughout the EU for Equioxx on 25 June 2008.

This authorisation was based on the authorisation granted to Previcox in 2004 (‘informed consent’).

For more information about treatment with Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Equioxx : EPAR - Summary for the public BG = bălgarski 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public ES = español 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public CS = čeština 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public DA = dansk 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public DE = Deutsch 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public ET = eesti keel 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public EL = elliniká 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public EN = English 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public FR = français 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public IT = italiano 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public LV = latviešu valoda 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public LT = lietuvių kalba 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public HU = magyar 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public MT = Malti 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public NL = Nederlands 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public PL = polski 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public PT = português 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public RO = română 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public SK = slovenčina 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public SL = slovenščina 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public FI = suomi 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public SV = svenska 2008-06-30 2017-03-06
Equioxx : EPAR - Summary for the public HR = Hrvatski 2008-06-30 2017-03-06

This EPAR was last updated on 09/08/2017 .

Authorisation details

Product details

Product details for Equioxx
NameEquioxx
Agency product numberEMEA/V/C/000142
Active substance

firocoxib

International non-proprietary name (INN) or common name

firocoxib

Species Horses
Anatomical therapeutic chemical veterinary (ATCvet) codes QM01AH90








Publication details

Publication details for Equioxx
Marketing-authorisation holder

Ceva Sante Animale - Libourne

Revision7
Date of issue of marketing authorisation valid throughout the European Union25/06/2008

Contact address:

Ceva Sante Animale - Libourne
10 avenue de la Ballastière
33500 Libourne
France

Product information

Product information

29/06/2017  Equioxx -EMEA/V/C/000142 -T/0019

Name Language First published Last updated
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09
Equioxx : EPAR - Product Information HR = Hrvatski 2008-06-30 2017-08-09

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06
Equioxx : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2017-03-06

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products

Therapeutic indication

Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents