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).
Authorisation details
Product details | |
---|---|
Name |
Novem
|
Agency product number |
EMEA/V/C/000086
|
Active substance |
meloxicam
|
International non-proprietary name (INN) or common name |
meloxicam
|
Species |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QM01AC06
|
Publication details | |
---|---|
Marketing-authorisation holder |
Boehringer Ingelheim Vetmedica GmbH
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
02/03/2004
|
Contact address |
Binger Strasse 173 |
Product information
07/01/2022 Novem - EMEA/V/C/000086 - IG/1466/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Anti-inflammatory and anti-rheumatic 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.