Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products
AUTHORISED  

Product information
Invented name: Meloxidyl   
Auth. number : EU/2/06/070
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: Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
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.
For the relief of post-operative pain following dehorning in calves.
Pigs:
For use in non-infectious 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.
Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
For the relief of pain associated with equine colic.
Marketing Authorisation Holder: CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France
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
18/01/2007 Centralised - Authorisation EMEA/V/C/115 (2007)165 of 15/01/2007
29/01/2007 Centralised - Variation EMEA/V/C/115/IB/1
Updated with Decision(2007)4234 of 07/09/2007
11/09/2007 Centralised - Variation EMEA/V/C/115/IB/1 (2007)4234 of 07/09/2007
12/10/2009 Centralised - Variation EMEA/V/C/115/X/2 (2009)7849 of 08/10/2009
12/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/115/IA/5
15/03/2010 Centralised - Variation EMEA/V/C/115/IA/6
Updated with Decision(2010)6014 of 26/08/2010
30/03/2010 Centralised - Variation EMEA/V/C/115/X/3 (2010)2171 of 26/03/2010
09/07/2010 Centralised - Variation EMEA/V/C/115/IB/7
Updated with Decision(2011)563 of 27/01/2011
27/08/2010 Centralised - Variation EMEA/V/C/115/X/4 (2010)6014 of 26/08/2010
27/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/115/IA/8
01/02/2011 Centralised - Variation (2011)563 of 27/01/2011
14/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/115/IB/9
21/12/2011 Centralised - Variation EMEA/V/C/115/IB/10
Updated with Decision(2011)9943 of 19/12/2011
21/12/2011 Centralised - Renewal EMEA/V/C/115/R/11 (2011)9943 of 19/12/2011
08/06/2012 Centralised - Variation EMEA/V/C/115/IB/12
Updated with Decision(2012)7890 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7890 of 29/10/2012
21/12/2012 Centralised - Variation EMEA/V/C/115/IA/15
Updated with Decision(2013)9712 of 18/12/2013
20/12/2013 Centralised - Yearly update (2013)9712 of 18/12/2013
02/04/2014 Centralised - 2-Monthly update EMEA/V/C/115/IB/17 (2014)2249 of 31/03/2014
01/10/2015 Centralised - Variation EMEA/V/C/115/IB/20/G
Updated with Decision(2016)6445 of 03/10/2016
05/10/2016 Centralised - Yearly update (2016)6445 of 03/10/2016