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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/CVMP/417775/2008

EMEA/V/C/000086

EPAR summary for the public

Novem

meloxicam

This document is a summary of the European Public Assessment Report. 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 document 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 Novem?

Novem is a medicine that contains the active substance meloxicam. It is available as a solution for injection (5 mg/ml and 20 mg/ml).

What is Novem used for?

Novem is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways). It can be used in diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle. It can be used for the relief of post-operative pain following dehorning in calves, and as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.

In pigs, Novem is used in non-infectious locomotor disorders (diseases that affect the ability to move) to reduce the symptoms of lameness and inflammation, for the relief of operative pain associated with minor soft tissue surgery such as castration and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome). Septicaemia and toxaemia are conditions where bacteria circulate in the blood and produce harmful substances (toxins).

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How does Novem work?

Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins. As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.

How has Novem been studied?

Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in the above indications.

What benefit has Novem shown during the studies?

The studies showed that the addition of Novem to antibiotics therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone. Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.

What is the risk associated with Novem?

In cattle and pigs both subcutaneous and intramuscular 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 cattle and pigs in very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.

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 Novem. If the product is accidentally self-injected, the advice of a doctor should be sought immediately.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.

Cattle

The withdrawal period is 15 days for meat and five days for milk.

Pigs

The withdrawal period for meat is five days.

Why has Novem been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Novem are greater than any risks of treatment and they recommended that Novem should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion of this EPAR.

Novem

EMA/CVMP/41775/2008    Page 2/3

Other information about Novem:

The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004. Information on the prescription status of this product may be found on the label of the carton.

This summary was last updated in December 2012.

Novem

EMA/CVMP/41775/2008