Meloxoral

meloxicam

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Meloxoral?

Meloxoral is presented as a pale yellow oral suspension which is to be given mixed with food or directly into the mouth in dogs or cats. Meloxoral contains the active substance meloxicam in a strength of 0.5 mg/ml (cats) or 1.5 mg/ml (dogs) for the oral suspension. 

Meloxoral is a ‘generic’, which means that Meloxoral is similar to a ‘reference veterinary medicine’ already authorised in the European Union (Metacam). Studies have been carried out to prove that Meloxoral is ‘bioequivalent’ to the reference veterinary medicine which means that Meloxoral is equivalent to Metacam in the way it is absorbed and used by the body.

What is Meloxoral used for?

Meloxoral is used in dogs to relieve inflammation and pain in musculoskeletal disorders. It can be used for both acute disorders, such as those seen after an injury, and chronic (long-term) disorders. In cats Meloxoral is used to alleviate inflammation and pain in chronic musculoskeletal disorders.

How does Meloxoral work?

Meloxoral contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam acts by inhibition of prostaglandin synthesis. As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.

How has the effectiveness of Meloxoral been studied?

Studies looked at how Meloxoral was absorbed and its effects in the body, in comparison with Metacam.

What are the side-effects of Meloxoral?

Occasional side effects of Meloxoral are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal failure and apathy (lack of vitality). These side effects occur generally within the first week of treatment and are usually temporary and disappear once treatment has stopped. In very rare cases, they may be serious or fatal.

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

People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxoral. If the product is swallowed by a person, the advice of a doctor should be sought immediately. In the case of accidental ingestion medical advice should be sought immediately, showing the package leaflet or label to the physician.

Why has Meloxoral been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxoral has been shown to be bioequivalent to Metacam. Therefore the CVMP’s view was that, as for Metacam, Meloxoral’s benefits are greater than its risks to alleviate inflammation and pain in musculo-skeletal disorders and they recommended that Meloxoral should be given a marketing authorisation.

The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Meloxoral

The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxoral to LeVet B.V. on 19 November 2010. Information on the prescription status of this product may be found on the label of the carton.

Name Language First published Last updated
Meloxoral : EPAR - Summary for the public BG = bălgarski 2010-11-29  
Meloxoral : EPAR - Summary for the public ES = español 2010-11-29  
Meloxoral : EPAR - Summary for the public CS = čeština 2010-11-29  
Meloxoral : EPAR - Summary for the public DA = dansk 2010-11-29  
Meloxoral : EPAR - Summary for the public DE = Deutsch 2010-11-29  
Meloxoral : EPAR - Summary for the public ET = eesti keel 2010-11-29  
Meloxoral : EPAR - Summary for the public EL = elliniká 2010-11-29  
Meloxoral : EPAR - Summary for the public EN = English 2010-11-29  
Meloxoral : EPAR - Summary for the public FR = français 2010-11-29  
Meloxoral : EPAR - Summary for the public IT = italiano 2010-11-29  
Meloxoral : EPAR - Summary for the public LV = latviešu valoda 2010-11-29  
Meloxoral : EPAR - Summary for the public LT = lietuvių kalba 2010-11-29  
Meloxoral : EPAR - Summary for the public HU = magyar 2010-11-29  
Meloxoral : EPAR - Summary for the public MT = Malti 2010-11-29  
Meloxoral : EPAR - Summary for the public NL = Nederlands 2010-11-29  
Meloxoral : EPAR - Summary for the public PL = polski 2010-11-29  
Meloxoral : EPAR - Summary for the public PT = português 2010-11-29  
Meloxoral : EPAR - Summary for the public RO = română 2010-11-29  
Meloxoral : EPAR - Summary for the public SK = slovenčina 2010-11-29  
Meloxoral : EPAR - Summary for the public SL = slovenščina 2010-11-29  
Meloxoral : EPAR - Summary for the public FI = suomi 2010-11-29  
Meloxoral : EPAR - Summary for the public SV = svenska 2010-11-29  

This EPAR was last updated on 09/02/2017 .

Authorisation details

Product details

Product details for Meloxoral
NameMeloxoral
Agency product numberEMEA/V/C/000151
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QM01AC06



Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Meloxoral
Marketing-authorisation holder

Le Vet B.V.

Revision5
Date of issue of marketing authorisation valid throughout the European Union19/11/2010

Contact address:

Le Vet B.V.
Wilgenweg 7
3421 TV Oudewater
Netherlands

Product information

Product information

27/01/2017  Meloxoral -EMEA/V/C/000151 -IAIN/0007

Name Language First published Last updated
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09
Meloxoral : EPAR - Product Information SV = svenska 2010-11-29 2017-02-09

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
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21
Meloxoral : EPAR - All Authorised presentations SV = svenska 2010-11-29 2013-11-21

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products

Therapeutic indication

Cats

Alleviation of inflammation and pain in chronic musculoskeletal disorders.

Dogs

Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Meloxoral : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2011-05-16 2017-02-09

Initial marketing-authorisation documents

Name Language First published Last updated
Meloxoral : EPAR - Scientific Discussion SV = svenska 2010-11-29  
CVMP positive summary of opinion for Meloxoral SV = svenska 2010-09-14  

Authorised

This medicine is approved for use in the European Union

More information on Meloxoral