Onsior

Authorised

This medicine is authorised for use in the European Union

robenacoxib

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Onsior : EPAR - Medicine overview

Product information

Onsior : EPAR - Product Information

Onsior : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Onsior
• Active substance:
  robenacoxib
• International non-proprietary name (INN) or common name:
  robenacoxib

Pharmacotherapeutic group

• Anti-inflammatory and anti-rheumatic products, non-steroids
• Coxibs

Authorisation details

• EMA product number:
  EMEA/V/C/000127

Assessment history

Changes since initial authorisation of medicine

Onsior : EPAR - Procedural steps taken and scientific information after authorisation

Onsior-V-C-127-II-0024-G : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Onsior (II-0024-G)

Adopted Reference Number: EMA/CVMP/622008/2019

Onsior-V-C-127-II-0018-G : EPAR - Assessment Report - Variation

CVMP post-authorisation summary of positive opinion for Onsior

Adopted Reference Number: EMA/CVMP/843508/2017

CVMP post-authorisation summary of positive opinion for Onsior

Adopted Reference Number: EMA/CVMP/683698/2012

CVMP post-authorisation summary of positive opinion for Onsior

Adopted Reference Number: EMA/461234/2012

Initial marketing authorisation documents

Onsior : EPAR - Scientific Discussion

Onsior : EPAR - Procedural steps taken before authorisation

Committee for medicinal products for veterinary use summary of opinion: Onisor: International Non-proprietary Name (INN): Robenacoxib

Adopted Reference Number: EMEA/CVMP/508377/2008