Novem

meloxicam

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This 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 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 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 rehydration 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 postoperative 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 noninfectious 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).

How does Novem work?

Novem contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory 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 showed during the studies?

Studies in cattle 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.

Studies in pigs showed that Novem reduces the symptoms of lameness and inflammation in noninfectious locomotor disorders. Similarly, treatment of mastitis-metritis-agalactia syndrome with adjunctive treatment of Novem and an appropriate antibiotic was shown to be superior to an antibiotic therapy 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 that 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 it recommended that Novem should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion of this EPAR.

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.

Name Language First published Last updated
Novem : EPAR - Summary for the public BG = bălgarski 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public ES = español 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public CS = čeština 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public DA = dansk 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public DE = Deutsch 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public ET = eesti keel 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public EL = elliniká 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public EN = English 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public FR = français 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public IT = italiano 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public LV = latviešu valoda 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public LT = lietuvių kalba 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public HU = magyar 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public MT = Malti 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public NL = Nederlands 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public PL = polski 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public PT = português 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public RO = română 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public SK = slovenčina 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public SL = slovenščina 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public FI = suomi 2008-09-23 2013-02-28
Novem : EPAR - Summary for the public SV = svenska 2008-09-23 2013-02-28

This EPAR was last updated on 06/10/2016 .

Authorisation details

Product details

Product details for Novem
NameNovem
Agency product numberEMEA/V/C/000086
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species PigsCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQM01AC06

Publication details

Publication details for Novem
Marketing-authorisation holder

Boehringer Ingelheim Vetmedica GmbH

Revision9
Date of issue of marketing authorisation valid throughout the European Union02/03/2004

Contact address:

Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

Product information

27/09/2016  Novem -EMEA/V/C/000086 -IG-0722

Name Language First published Last updated
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06
Novem : EPAR - Product Information SV = svenska 2009-03-16 2016-10-06

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
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13
Novem : EPAR - All Authorised presentations SV = svenska 2009-03-16 2012-02-13

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products, non-steroids

Therapeutic indication

Novem 5-mg/ml solution for injection for cattle and pigs:

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 the relief of postoperative pain following dehorning in calves.

Pigs

For use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For the relief of postoperative pain associated with minor soft-tissue surgery such as castration.

Novem 20-mg/ml solution for injection for cattle and pigs:

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.

For the relief of postoperative pain following dehorning in calves.

Pigs

For use in noninfectious 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. 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Novem : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-03-20 2016-10-06
Novem-V-C-86-WS-0264 : EPAR - Assessment Report - Variation SV = svenska 2013-07-26  

Initial marketing-authorisation documents

Name Language First published Last updated
Novem : EPAR - Scientific Discussion SV = svenska 2006-10-05