Novem
Authorised
This medicine is authorised for use in the European Union
meloxicam
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information:
IG/1466/G
07/01/2022
Product details
- Name of medicine
- Novem
- Active substance
- meloxicam
- International non-proprietary name (INN) or common name
- meloxicam
- Species
- Pigs
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QM01AC06
Pharmacotherapeutic group
Anti-inflammatory and anti-rheumatic products, non-steroidsTherapeutic 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.
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