Draxxin RSS Authorised This medicine is authorised for use in the European Union tulathromycin Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Draxxin More information on Draxxin More information on Draxxin Topics Application under evaluation CVMP opinion European Commission decision OverviewUp-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website Draxxin : EPAR - Summary for the public English (EN) (81.94 KB - PDF)First published: 03/10/2008 Last updated: 04/09/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View español (ES) (81.97 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View čeština (CS) (93.99 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View dansk (DA) (83.34 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View français (FR) (82.44 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View íslenska (IS) (83.29 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View italiano (IT) (82.29 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View magyar (HU) (94.15 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Malti (MT) (95.95 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View norsk (NO) (82 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View polski (PL) (95.62 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View português (PT) (83.01 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View română (RO) (94.17 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View slovenčina (SK) (94.08 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View slovenščina (SL) (82.27 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Suomi (FI) (81.54 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View svenska (SV) (82.05 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Product information Draxxin : EPAR - Product Information English (EN) (81.49 KB - PDF)First published: 03/10/2008 Last updated: 04/09/2025 View Other languages (25) български (BG) (91.78 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View español (ES) (81.51 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View čeština (CS) (92.48 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View dansk (DA) (82.05 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Deutsch (DE) (81.72 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View eesti keel (ET) (81.22 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View ελληνικά (EL) (91.79 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View français (FR) (81.63 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View hrvatski (HR) (91.56 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View íslenska (IS) (81.52 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Gaeilge (GA) (81.36 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View italiano (IT) (81.76 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View latviešu valoda (LV) (92.14 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View magyar (HU) (92.76 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Malti (MT) (93.86 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Nederlands (NL) (81.15 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View norsk (NO) (81.52 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View polski (PL) (93.22 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View português (PT) (82.53 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View română (RO) (91.73 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View slovenčina (SK) (81.75 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View slovenščina (SL) (81.76 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Suomi (FI) (81.11 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View svenska (SV) (81.47 KB - PDF) First published: 03/10/2008 Last updated: 04/09/2025 View Draxxin : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)First published: 25/06/2008 Last updated: 04/09/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View español (ES) (81.97 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View čeština (CS) (93.99 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View dansk (DA) (83.34 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View français (FR) (82.44 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View íslenska (IS) (83.29 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View italiano (IT) (82.29 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View magyar (HU) (94.15 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View Malti (MT) (95.95 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View norsk (NO) (82 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View polski (PL) (95.62 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View português (PT) (83.01 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View română (RO) (94.17 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View slovenčina (SK) (94.08 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View slovenščina (SL) (82.27 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View Suomi (FI) (81.54 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View svenska (SV) (82.05 KB - PDF) First published: 25/06/2008 Last updated: 04/09/2025 View Product details Name of medicine Draxxin Active substance tulathromycin International non-proprietary name (INN) or common name tulathromycin Pharmacotherapeutic groupAntibacterials for systemic use Authorisation details EMA product number EMEA/V/C/000077 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Draxxin : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 03/10/2008 Last updated: 04/09/2025 View Draxxin-V-C-77-X-0029 : EPAR - Assessment Report - ExtensionAdopted Reference Number: EMA/604738/2016 English (EN) (81.49 KB - PDF)First published: 28/11/2016 Last updated: 04/09/2025 View CVMP post-authorisation summary of positive opinion for DraxxinIIAdopted Reference Number: EMA/CVMP/586537/2016 English (EN) (67.03 KB - PDF)First published: 09/09/2016 Last updated: 09/09/2016 View Draxxin-V-C-0077-II-0031: EPAR - Assessment Report - VariationAdopted Reference Number: EMA/150039/2016 English (EN) (81.49 KB - PDF)First published: 02/06/2016 Last updated: 04/09/2025 View CVMP post-authorisation summary of negative opinion for DraxxinAdopted Reference Number: EMA/CVMP/289817/2016 English (EN) (67.3 KB - PDF)First published: 20/05/2016 Last updated: 20/05/2016 View CVMP post-authorisation summary of positive opinion for DraxxinAdopted Reference Number: EMEA/CVMP/65204/2016 English (EN) (60.72 KB - PDF)First published: 19/02/2016 Last updated: 19/02/2016 View Draxxin-V-C-0077-II-0034: EPAR - Assessment Report - VariationAdopted Reference Number: EMA/CVMP/170888/2015 English (EN) (81.49 KB - PDF)First published: 13/05/2015 Last updated: 04/09/2025 View CVMP post-authorisation summary of positive opinion for DraxxinAdopted Reference Number: EMA/CVMP/156049/2015 English (EN) (67.44 KB - PDF)First published: 13/03/2015 Last updated: 13/03/2015 View Draxxin-V-C-77-X-26 : EPAR - Assessment Report - ExtensionAdopted Reference Number: EMA/289318/2014 English (EN) (125.9 KB - PDF)First published: 26/08/2014 Last updated: 26/08/2014 View CVMP post-authorisation summary of positive opinion for DraxxinAdopted Reference Number: EMA/CVMP/233183/2014 English (EN) (68 KB - PDF)First published: 12/05/2014 Last updated: 12/05/2014 View Initial marketing authorisation documents Draxxin : EPAR - Scientific Discussion English (EN) (309.92 KB - PDF)First published: 02/09/2008 Last updated: 09/04/2010 View Draxxin : EPAR - Procedural steps taken before authorisation English (EN) (20.1 KB - PDF)First published: 02/09/2008 Last updated: 02/09/2008 View News on Draxxin Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 9-10 September 202512/09/2025 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 202416/02/2024 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 202117/05/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 202025/05/2020 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-22 May 201924/05/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 April 201718/04/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 September 201609/09/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 May 201620/05/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 16-18 February 201619/02/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 March 201513/03/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 July 201411/07/2014 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 May 201412/05/2014 Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 13-15 April 201016/04/2010 Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 February 201012/02/2010 More information on Draxxin Divergent position on a CVMP opinion on a type II variation to the terms of the marketing authorisation for DRAXXIN (EMEA/V/C/000077/II/0031) English (EN) (73.85 KB - PDF)First published: 02/06/2016 Last updated: 02/06/2016 View More information on Draxxin Draxxin - withdrawal of application for variation to marketing authorisationDraxxin - withdrawal of application for variation to marketing authorisation Topics Medicines This page was last updated on 04/09/2025 Share this page