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 and what is it used for?

Novem is an anti-inflammatory medicine used in cattle and pigs. It contains the active substance meloxicam.

In cattle, Novem is used to treat:

  • acute respiratory infection (infection of the lungs and airways) together with antibiotics
  • diarrhoea in calves of over one week of age and young, non-lactating cattle together with oral re-hydration therapy (medicines given by mouth to restore water levels in the body)
  • pain following dehorning in calves
  • acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.

In pigs, Novem is used to treat:

  • lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move)
  • pain following minor soft tissue surgery such as castration
  • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) together with the main treatment with antibiotics.
How is Novem used?

Novem is available as a solution for injection and can only be obtained with a prescription. The dose to use depends on the animal and its bodyweight. Injections are given under the skin for cattle and into the muscles for pigs.

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.

What benefits of Novem have been shown in studies?

Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses. The studies showed that the addition of Novem to antibiotic 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 are the risks 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 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 in food-producing animals?

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 is Novem approved?

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

Other information about Novem

The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004. For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Novem : EPAR - Summary for the public BG = bălgarski 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public ES = español 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public CS = čeština 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public DA = dansk 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public DE = Deutsch 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public ET = eesti keel 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public EL = elliniká 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public EN = English 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public FR = français 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public IT = italiano 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public LV = latviešu valoda 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public LT = lietuvių kalba 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public HU = magyar 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public MT = Malti 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public NL = Nederlands 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public PL = polski 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public PT = português 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public RO = română 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public SK = slovenčina 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public SL = slovenščina 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public FI = suomi 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public SV = svenska 2008-09-23 2017-06-02
Novem : EPAR - Summary for the public HR = Hrvatski 2008-09-23 2017-06-02

This EPAR was last updated on 02/06/2017 .

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) codes QM01AC06







Publication details

Publication details for Novem
Marketing-authorisation holder

Boehringer Ingelheim Vetmedica GmbH

Revision10
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

15/05/2017  Novem -EMEA/V/C/000086 -X/0018

Name Language First published Last updated
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - Product Information HR = Hrvatski 2009-03-16 2017-06-02

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 HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02
Novem : EPAR - All Authorised presentations HR = Hrvatski 2009-03-16 2017-06-02

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.

Novem 40 mg/ml solution for injection for 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 re-hydration 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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

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