Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Onsior   
Auth. number : EU/2/08/089
INN : Robenacoxib
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: QM01AH - Coxibs
Chemical substance: QM01AH91 - Robenacoxib
(See WHO ATCvet Index)
Indication: Tablets for cats: treatment of acute pain and inflammation associated with musculo-skeletal disorders in cats, reduction of moderate pain and inflammation associated with orthopaedic surgery in cats.
Tablets for dogs: treatment of pain and inflammation associated with chronic osteoarthritis in dogs.
Solution for injection for cats and dogs: treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs and soft tissue surgery in cats, treatment of pain and inflammation associated with orthopaedic surgery in cats (including repeated post surgery indication)
Marketing Authorisation Holder: Novartis Animal Health UK Ltd
Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom

  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
18/12/2008 Centralised - Authorisation EMEA/V/C/127 (2008)8731 of 16/12/2008
21/05/2009 Centralised - Variation EMEA/V/C/127/II/1 (2009)4097 of 19/05/2009
16/06/2009 Centralised - Variation EMEA/V/C/127/IA/2
Updated with Decision(2009)10748 of 22/12/2009
15/10/2009 Centralised - Variation EMEA/V/C/127/IA/3
24/12/2009 Centralised - Variation (2009)10748 of 22/12/2009
18/11/2011 Centralised - Variation EMEA/V/C/127/IB/5/G
Updated with Decision(2012)3636 of 25/05/2012
01/06/2012 Centralised - Variation (2012)3636 of 25/05/2012
15/02/2013 Centralised - Variation EMEA/V/C/127/II/6/G (2013)939 of 13/02/2013
13/11/2013 Centralised - Renewal EMEA/V/C/127/R/10 (2013)7871 of 08/11/2013