Novem

RSS

meloxicam

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 07/09/2017

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
  • Pigs
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QM01AC06
Publication details
Marketing-authorisation holder
Boehringer Ingelheim Vetmedica GmbH
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
02/03/2004
Contact address
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

01/09/2017 Novem - EMEA/V/C/000086 - IG/0831

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.

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

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