Meloxidyl

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 Meloxidyl?

Meloxidyl is a medicinal product that contains the active substance meloxicam. Meloxidyl is a pale green oral suspension (1.5 mg/ml) for dogs and (0.5 mg/ml) for cats, which is mixed into the food, and a yellow solution for injection (5 mg/ml) for dogs and cats as well as solution for injection (20 mg/ml) for cattle, pigs and horses.

Meloxidyl is a ‘generic’: this means that Meloxidyl is similar to a ‘reference veterinary medicinal product’ already authorised in the European Union (EU; Metacam). Studies have been carried out to prove that Meloxidyl is ‘bioequivalent’ to the reference veterinary medicinal product: this means that Meloxidyl is equivalent to Metacam in the way it is absorbed and used by the body.

What is Meloxidyl used for?

In dogs, Meloxidyl is used as an oral suspension to relieve inflammation and pain in musculoskeletal disorders. It can be used for both acute (sudden) disorders, such as those seen after an injury, and chronic (long-term) disorders. As an injection, Meloxidyl is also used to reduce the pain and inflammation after an operation, such as orthopaedic or soft-tissue surgery.

In cats, Meloxidyl is used as an oral suspension to relieve inflammation and pain in chronic musculoskeletal disorders as well as to relieve mild to moderate pain after an operation, such as spaying or soft-tissue surgery. Meloxidyl injection is used in cats to reduce the pain after an operation, such as spaying or minor soft-tissue surgery.

In cattle, Meloxidyl injection is used to reduce clinical signs in case of acute respiratory infection with appropriate antibiotic therapy, to reduce clinical signs in case of diarrhoea in combination with oral rehydration therapy in calves over one week of age and young, non-lactating cattle and as supportive therapy in the treatment of acute mastitis, in combination with antibiotics.

In pigs, Meloxidyl injection is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders and for supportive therapy in the treatment of puerperal septicaemia and toxaemia around farrowing (mastitis-metritis-agalactia syndrome) with appropriate antibiotics.

In horses, Meloxidyl injection is used to relieve inflammation and pain in both acute and chronic musculoskeletal disorders and for the relief of pain associated with colic.

How does Meloxidyl work?

Meloxidyl 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 Meloxidyl been studied?

A study looked at how Meloxidyl was absorbed and its effects in the body, in comparison with Metacam.

What benefit has Meloxidyl shown during the studies?

Based on the findings of the study, Meloxidyl was considered to be bioequivalent to the reference medicinal product. Because of this, Meloxidyl’s benefit is taken as being the same as that of the reference medicinal product.

What is the risk associated with Meloxidyl?

In dogs and cats, the side effects seen with Meloxidyl are similar to those seen with other NSAIDs and occur only occasionally. They include loss of appetite, vomiting, diarrhoea, blood in the stools and apathy (lack of vitality). They usually occur during the first week of treatment and tend to be temporary. They disappear once treatment has stopped. In very rare cases, they may be serious or fatal.

In cattle and pigs, subcutaneous, intramuscular and intravenous administration are well tolerated. Only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.

In horses, anaphlylactoid (hypersensitivity) reactions can occur and should be treated symptomatically. A temporary swelling at the injection site can occur but resolves without intervention.

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

People who are hypersensitive to NSAIDs should avoid contact with Meloxidyl. If someone swallows the medicinal product, the advice of a doctor should be sought immediately. Accidental self-injection may cause pain. If this happens, seek medical advice immediately and show the package leaflet or the label to the doctor.

What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

After the last administration of Meloxidyl cattle should not be slaughtered for 15 days and the milk not used for 5 days. Pigs and horses should not be slaughtered for 5 days.

Why has Meloxidyl been approved

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Meloxidyl has been shown to be bioequivalent to Metacam. Therefore the CVMP’s view was that, as for Metacam, Meloxidyl’s benefits are greater than its risks. The Committee recommended that Meloxidyl should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Meloxidyl

The European Commission granted a marketing authorisation valid throughout the European Union for Meloxidyl to Ceva Santé Animale on 15 January 2007. Information on the prescription status of this product may be found on the label of the carton.

Name Language First published Last updated
Meloxidyl : EPAR - Summary for the public BG = bălgarski 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public ES = español 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public CS = čeština 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public DA = dansk 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public DE = Deutsch 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public ET = eesti keel 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public EL = elliniká 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public EN = English 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public FR = français 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public IT = italiano 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public LV = latviešu valoda 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public LT = lietuvių kalba 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public HU = magyar 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public MT = Malti 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public NL = Nederlands 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public PL = polski 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public PT = português 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public RO = română 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public SK = slovenčina 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public SL = slovenščina 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public FI = suomi 2009-10-09 2010-09-06
Meloxidyl : EPAR - Summary for the public SV = svenska 2009-10-09 2010-09-06

This EPAR was last updated on 08/10/2015 .

Authorisation details

Product details

Product details for Meloxidyl
NameMeloxidyl
Agency product numberEMEA/V/C/000115
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species HorsesDogsPigsCatsCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQM01AC06
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 Meloxidyl
Marketing-authorisation holder

Ceva Santé Animale

Revision12
Date of issue of marketing authorisation valid throughout the European Union15/01/2007

Contact address:

Ceva Santé Animale
10 avenue de la Ballastière
33500 Libourne
France

Product information

Product information

01/10/2015  Meloxidyl -EMEA/V/C/000115 -IB/0020/G

Name Language First published Last updated
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08
Meloxidyl : EPAR - Product Information SV = svenska 2009-10-09 2015-10-08

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
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08
Meloxidyl : EPAR - All Authorised presentations SV = svenska 2009-08-14 2015-10-08

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products, non-steroids (oxicams)

Therapeutic indication

Dogs

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

Reduction of post-operative pain and inflammation following orthopaedic and soft-tissue surgery.

Cats

Reduction of post-operative pain after ovariohysterectomy and minor soft-tissue surgery.

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

Pigs

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.

For the relief of pain associated with equine colic.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Meloxidyl : EPAR - Scientific Discussion SV = svenska 2009-10-16 2010-09-06
Meloxidyl : EPAR - Procedural steps taken before authorisation SV = svenska 2007-04-02  

Authorised

This medicine is approved for use in the European Union

More information on Meloxidyl