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Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Melovem   
Auth. number : EU/2/09/098
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: Melovem 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 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.
Pigs:
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.

Melovem 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 coli

Melovem 30 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 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.
If variation(s): Scope of variation(s): IB 7 (2 Monthly decision)
Marketing Authorisation Holder: Dopharma Research B.V.
Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland

  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
09/07/2009 Centralised - Authorisation EMEA/V/C/152 (2009)5592 of 07/07/2009
09/04/2010 Centralised - Variation EMEA/V/C/152/IB/1
Updated with Decision(2010)7718 of 03/11/2010
14/07/2010 Centralised - Variation EMEA/V/C/152/IA/2/G
08/11/2010 Centralised - Variation (2010)7718 of 03/11/2010
27/09/2013 Centralised - Variation EMEA/V/C/152/X/3, 4 (2013)6343 of 25/09/2013
10/02/2014 Centralised - Variation EMEA/V/C/152/IB/7 (2014)787 of 06/02/2014
11/06/2014 Centralised - Renewal EMEA/V/C/152/R/8 (2014)3941 of 06/06/2014