Draxxin

Authorised

This medicine is authorised for use in the European Union

tulathromycin

Overview

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

Draxxin : EPAR - Summary for the public

Product information

Draxxin : EPAR - Product Information

Draxxin : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Antibacterials for systemic use

Authorisation details

• EMA product number:
  EMEA/V/C/000077

Assessment history

Changes since initial authorisation of medicine

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

Draxxin-V-C-77-X-0029 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/604738/2016

CVMP post-authorisation summary of positive opinion for DraxxinII

Adopted Reference Number: EMA/CVMP/586537/2016

Draxxin-V-C-0077-II-0031: EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/150039/2016

CVMP post-authorisation summary of negative opinion for Draxxin

Adopted Reference Number: EMA/CVMP/289817/2016

CVMP post-authorisation summary of positive opinion for Draxxin

Adopted Reference Number: EMEA/CVMP/65204/2016

Draxxin-V-C-0077-II-0034: EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CVMP/170888/2015

CVMP post-authorisation summary of positive opinion for Draxxin

Adopted Reference Number: EMA/CVMP/156049/2015

Draxxin-V-C-77-X-26 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/289318/2014

CVMP post-authorisation summary of positive opinion for Draxxin

Adopted Reference Number: EMA/CVMP/233183/2014

Initial marketing authorisation documents

Draxxin : EPAR - Scientific Discussion

Draxxin : EPAR - Procedural steps taken before authorisation