Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Novem   
Auth. number : EU/2/04/042
Active substance : Meloxicam
ATC: Anatomical main group: QM - Musculo-skeletal system
Therapeutic subgroup: QM01 - Antiinflammatory and antirheumatic products
Pharmacological subgroup: QM01A - Antiinflammatory and antirheumatic products, non-steroids
Chemical subgroup: QM01AC - Oxicams
Chemical substance: QM01AC06 - meloxicam
(See WHO ATCvet Index)
Indication: 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 the relief of post-operative pain following dehorning in calves.
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For the relief of post-operative pain associated with minor soft tissue surgery such as castration.
Marketing Authorisation Holder: Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/03/2004 Centralised - Authorisation EMEA/V/C/86 (2004)737 of 02/03/2004
25/02/2005 Centralised - Notification EMEA/V/C/86/N/2
Updated with Decision(2005)3291 of 25/08/2005
29/08/2005 Centralised - Variation EMEA/V/C/86/X/3 (2005)3291 of 25/08/2005
24/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/86/II/4
22/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/86/IB/6
16/01/2009 Centralised - Renewal EMEA/V/C/86/R/5 (2009)140 of 13/01/2009
16/03/2009 Centralised - Variation EMEA/V/C/86/II/7 (2009)1968 of 12/03/2009
18/10/2010 Centralised - Variation EMEA/V/C/86/II/8/G (2010)7222 of 14/10/2010
03/01/2012 Centralised - Variation EMEA/V/C/86/IB/9/G
Updated with Decision(2012)5016 of 12/07/2012
03/01/2012 Centralised - Variation EMEA/V/C/86/IB/10
Updated with Decision(2012)5016 of 12/07/2012
17/07/2012 Centralised - Variation (2012)5016 of 12/07/2012
12/03/2013 Centralised - Variation EMEA/V/C/86/WS/264 (2013)794 of 08/02/2013
15/01/2015 Centralised - Variation EMEA/V/C/86/WS/661/15/G
Updated with Decision(2015)9746 of 18/12/2015
22/12/2015 Centralised - Yearly update (2015)9746 of 18/12/2015
27/09/2016 Centralised - Variation EMEA/V/C/86/IG/722/17
Updated with Decision(2017)3403 of 15/05/2017
17/05/2017 Centralised - Variation EMEA/V/C/86/X/18 (2017)3403 of 15/05/2017
01/09/2017 Centralised - Variation EMEA/V/C/86/IG/831