Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Loxicom   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Loxicom /Локсиком/ (BG)
Auth. number : EU/2/08/090
INN : 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: Loxicom 0.5 mg/ml oral suspension for dogs / Loxicom 1.5 mg/ml oral suspension for dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Loxicom 5 mg/ml solution for injection for dogs and cats:
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.

Loxicom 0.5 mg/ml oral suspension for cats: Alleviation of inflammation and pain in chronic musculo-skeletal disorders in cats.

Loxicom 20 mg/ml solution for injection for cattle, pigs and horses:
 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.

Loxicom 1 mg chewable tablets for dogs / Loxicom 2.5 mg chewable tablets for dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Loxicom 50 mg/g oral paste for horses: Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
Marketing Authorisation Holder: Norbrook Laboratories Ltd
Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

  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
12/02/2009 Centralised - Authorisation EMEA/V/C/141 (2009)1021 of 10/02/2009
28/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/141/II/2
25/03/2010 Centralised - Variation EMEA/V/C/141/II/1 (2010)2027 of 23/03/2010
07/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/141/IAin/4
18/07/2010 Centralised - Variation EMEA/V/C/141/X/3 (2011)5206 of 13/07/2010
20/09/2010 Centralised - Variation EMEA/V/C/141/X/5 (2011)6601 of 16/09/2010
21/09/2011 Centralised - Variation EMEA/V/C/141/IB/7
Updated with Decision(2012)2831 of 20/04/2012
18/11/2011 Centralised - Variation EMEA/V/C/141/IB/8
Updated with Decision(2012)2831 of 20/04/2012
25/11/2011 Centralised - Variation EMEA/V/C/141/IB/10
Updated with Decision(2012)2831 of 20/04/2012
24/04/2012 Centralised - Variation (2012)2831 of 20/04/2012
27/09/2012 Centralised - Variation EMEA/V/C/141/IB/13
Updated with Decision(2012)7879 of 29/10/2012
05/10/2012 Centralised - Variation EMEA/V/C/141/IB/12
Updated with Decision(2012)7879 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7879 of 29/10/2012
08/03/2013 Centralised - Variation EMEA/V/C/141/X/9 (2013)1418 of 06/03/2013
10/06/2013 Centralised - Variation EMEA/V/C/141/IB/15
Updated with Decision(2014)1737 of 12/03/2014
10/06/2013 Centralised - Variation EMEA/V/C/141/IB/16
Updated with Decision(2014)1737 of 12/03/2014
10/06/2013 Centralised - Variation EMEA/V/C/141/IB/14
Updated with Decision(2014)1737 of 12/03/2014
14/11/2013 Centralised - Variation EMEA/V/C/141/IAin/19
Updated with Decision(2014)1737 of 12/03/2014
14/03/2014 Centralised - Renewal EMEA/V/C/141/R/18 (2014)1737 of 12/03/2014